The following data is part of a premarket notification filed by Wuxi Exanovo Medical Instrument Co., Ltd. with the FDA for Aneroid Sphygmomanometer.
| Device ID | K203620 |
| 510k Number | K203620 |
| Device Name: | Aneroid Sphygmomanometer |
| Classification | Blood Pressure Cuff |
| Applicant | Wuxi Exanovo Medical Instrument Co., Ltd. No. 42, Xixin Road, Zhangjing, Xibei Town Wuxi, CN 214194 |
| Contact | Xiao Huang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2021-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970691000068 | K203620 | 000 |
| 06970691000211 | K203620 | 000 |
| 06970691000228 | K203620 | 000 |
| 06970691000235 | K203620 | 000 |
| 06970691000242 | K203620 | 000 |
| 06970691000259 | K203620 | 000 |
| 06970691000266 | K203620 | 000 |
| 06970691000037 | K203620 | 000 |
| 06970691000044 | K203620 | 000 |
| 06970691000051 | K203620 | 000 |
| 06970691000273 | K203620 | 000 |