The following data is part of a premarket notification filed by Wuxi Medical Instrument Factory with the FDA for Disposable Blood Pressure Cuff.
| Device ID | K102823 |
| 510k Number | K102823 |
| Device Name: | DISPOSABLE BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | WUXI MEDICAL INSTRUMENT FACTORY P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WUXI MEDICAL INSTRUMENT FACTORY P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-01-07 |
| Summary: | summary |