CTM-300
6 catalogue numbers from 2879-07-15, listed by IVY Biomedical Systems, Inc., United States, under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
6catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (1), Hebei (1). 2 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 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | IVY Biomedical Systems, Inc., United States |
|---|---|
| FDA product code | DRT |
| Device type | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K083854 |
| Record published | 2016-10-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Weight 2.5 lb; depth 5.5 in; width 7.5 in; height 2.5 in |
| Distribution end date | 2016-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2879-07-15 | Weight 2.5 lb | In distribution |
| 2879-05-15 | Weight 2.5 lb | In distribution |
| 2882-03-01 | Weight 2.5 lb | In distribution |
| 2879-06-15 | Weight 2.5 lb | In distribution |
| 2882-02-01 | Weight 2.5 lb | In distribution |
| 2879-04-15 | Weight 2.5 lb | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Model 7600 | IVY Biomedical Systems, Inc. | 82 |
| Model 7800 | IVY Biomedical Systems, Inc. | 66 |
| ECG | Zoll Medical Corporation | 30 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden America, Inc. | 18 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden Corp. | 12 |
| Model 7600EP | IVY Biomedical Systems, Inc. | 11 |
| Propaq M | Zoll Medical Corporation | 11 |
| Model 7700 | IVY Biomedical Systems, Inc. | 11 |
| Cable | Zoll Medical Corporation | 5 |
| Upmm | IVY Biomedical Systems, Inc. | 4 |
| ViSi | Sotera Wireless | 4 |
| Anybattery | Anybattery, Inc | 3 |
Showing 12 of 43. All products under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202138 | 2021-05-14 |
| K170828 | 2017-05-17 |
| K151781 | 2016-05-27 |
| K110987 | 2011-07-22 |
| K091985 | 2009-07-24 |
| K083854 | 2009-02-13 |
| K023616 | 2002-11-04 |
| K884455 | 1989-03-09 |
| K884096 | 1989-02-23 |
| K880066 | 1988-03-22 |
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.