Sensor
Piezo Respiratory Effort Sensor, Adult, Buckle Style (CT2 A, Alice 5)
8manufacturers in China registered for this device type
42catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Hebei (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Dongguan Smart Manufacturing Partner Electronic Company Limited | Dongguan | Guangdong | Contract manufacturer | 1 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | BZQ |
| Device type | Monitor, Breathing Frequency |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K923402 |
| Record published | 2016-09-01 |
| Record revised | 2021-03-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TWO CHANNEL PLUS KIT PEDIATRIC 1″ | In distribution | |
| CT2 A Chest Pocket | In distribution | |
| PLM SENSOR KIT | In distribution | |
| NK Piezo Sensor | In distribution | |
| ADULT VELCRO STRAP KIT 1.5″ | In distribution | |
| AFS 1 CH.ADULT CANN.STYLE AL4 | In distribution | |
| PIEZO RESP. EFF. SEN. ADLT. BUCKLE STYLE | In distribution | |
| Piezo 1 CH A/P 1.5″ Kit | In distribution | |
| GRASS Piezo Sensor P | In distribution | |
| PIEZO SENSOR STRAP 1.5″ (CT1) | In distribution | |
| PEDIATRIC VELCRO STRAP KIT 1″ | In distribution | |
| THERMISTOR AIRFLOW SENSR,1 CH, PED RESP | In distribution | |
| CT2 PIEZO RESP.EFFORT SEN.PED. | In distribution | |
| GRASS VELCRO STRAP KIT P | In distribution | |
| Airflow Sensor Thermistor, Oral, 249 | In distribution | |
| ONE CHANNEL KIT ADULT 1.5″ | In distribution | |
| PLM Sensor, 249 | In distribution | |
| THERMISTOR, ORAL, ALICE PDX | In distribution | |
| Airflow Sensor Thermistory 1 Pediatric Embletta | In distribution | |
| CT2 A Embletta | In distribution | |
| Airflow Thermistor,.10k Adult | In distribution | |
| PEDIATRIC VELCRO STRAP KIT 1.5″ | In distribution | |
| CT2 EFFORT SENSOR,PEDIATRIC,ALICE 5,RESP | In distribution | |
| GRASS Piezo Effort 1 CH P Kit | In distribution | |
| PEDIATRIC PIEZO SENSOR STRAP 1″ | In distribution | |
| VELCRO STRAP PLM,LG,41CM-16″ | In distribution | |
| VELCRO STRAP PLM,SMALL,20CM-8″ | In distribution | |
| THERMIS AIR FLOW 1 CH ADULT EMBLETTA | In distribution | |
| THERMISTOR AIRFLOW SENSOR,1 CH, NEONATE RESP | In distribution | |
| THERMISTOR SENSOR, ADULT, STARDUST | In distribution | |
| TWO CHANNEL PLUS KIT ADULT 1.5″ | In distribution | |
| PLM SENSOR KIT | In distribution | |
| CT2 PIEZO RESP EFFORT SEN.ADULT | In distribution | |
| CT2 Effort Sensor Adult, Stardust | In distribution | |
| GRASS VELCRO STRAP KIT A | In distribution | |
| NK Piezo Effort 1 CH A Kit | In distribution | |
| NK Piezo Effort 1 CH P Kit 1.5″ | In distribution | |
| WIRESET, JUMPER, 1.5mm MALE | In distribution | |
| PLM SENSOR | In distribution | |
| PIEZO 1 CH PEDIATRIC KIT | In distribution | |
| THERMISTOR NASAL ORAL, ADULT, ALICE PDX | In distribution | |
| AIR FLOW,THER.10K,ADULT,1 CH,1.5MM SAFETY | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfect Fit | Dymedix Diagnostics Inc | 189 |
| Monitor, Breathing Frequency | ConMed Corporation | 106 |
| Monitor, Breathing Frequency | Salter Labs | 52 |
| Conmed | ConMed Corporation | 46 |
| Cadwell | Cadwell Industries, Inc. | 44 |
| ThermiSense | Salter Labs | 33 |
| SnuggleFit | Dymedix Diagnostics Inc | 23 |
| Braebon Cable for Disposable RIP | Braebon Medical Corp. | 5 |
| PneumoTherm | Salter Labs | 4 |
| BiNAPS | Salter Labs | 4 |
| SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice | Ambu A/S | 4 |
| Braebon PT2 Dual Differntial Airflow Pressure Kit | Braebon Medical Corp. | 3 |
Showing 12 of 248. All products under Monitor, Breathing Frequency
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K982550 | 1998-10-05 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-06-04 | Not classified | Other | Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected. | 2726 units | 2005-01-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.