M Series CCT
Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,NELLCOR,REFURB
12manufacturers in China registered for this device type
33catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (1), Shanghai (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 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| 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 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | Guangdong | Specification developer | 7 |
Record
| Listed by | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | DSK |
| Device type | Computer, Blood-Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1110 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2014-09-19 |
| Record revised | 2026-02-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment atmospheric pressure from 0 KiloPascal; Storage environment humidity 5 to 95 % RH; Handling environment temperature 0 to 50 °C |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40021961100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60021911100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60021811100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021911100124300 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60010911101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60021761100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021911100024010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60022911100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021921100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021911100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021911101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60010811100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60022931100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40022911100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40022961100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010961100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021811101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021811100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010921100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010811100024010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010911101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010911100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021911101024010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60010911100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60021961100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010961101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010861101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60021911101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010811101124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40010811100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60010811100024010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 40021761100124010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
| 60021911100024010 | 10.2″ x 10.3″ x 8.7″ | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Computer, Blood-Pressure | St. Jude Medical | 39 |
| Zurich Medical Accessory Cable | Zurich Medical Inc | 33 |
| PressureWire™ | St. Jude Medical | 11 |
| Propaq M | Zoll Medical Corporation | 10 |
| Safedraw™ | Argon Critical Care Systems Singapore PTE. Ltd. | 8 |
| Computer, Blood-Pressure | Physio-Control, Inc. | 7 |
| SJM™ | St. Jude Medical | 4 |
| Quantien™ | St. Jude Medical | 4 |
| SureSigns VSi | Philips Medical Systems Hsg | 3 |
| Avvigo™ Guidance System | Boston Scientific Corporation | 2 |
| SureSigns VS2+ | Philips Medical Systems Hsg | 2 |
| X Series | Zoll Medical Corporation | 2 |
Showing 12 of 36. All products under Computer, Blood-Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K011865 | 2001-07-31 |
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.