The following data is part of a premarket notification filed by Wenzhou Renhua Instruments Co., Ltd with the FDA for Rh Non-automated Blood Pressure Meter Rh Non-automated Blood Pressure Meter With Stethoscope.
| Device ID | K190902 |
| 510k Number | K190902 |
| Device Name: | RH Non-Automated Blood Pressure Meter RH Non-Automated Blood Pressure Meter With Stethoscope |
| Classification | Blood Pressure Cuff |
| Applicant | Wenzhou Renhua Instruments Co., Ltd #.1-1704 Wanda Business Building Yongding Road, Longwan Wenzhou, CN 325024 |
| Contact | Wang Saijie |
| Correspondent | Wang Saijie Wenzhou Renhua Instruments Co., Ltd #.1-1704 Wanda Business Building Yongding Road, Longwan Wenzhou, CN 325024 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-08 |
| Decision Date | 2019-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856324008372 | K190902 | 000 |
| 00850029189916 | K190902 | 000 |
| 00850029189763 | K190902 | 000 |
| 00850029189770 | K190902 | 000 |
| 00850029189787 | K190902 | 000 |
| 08500139032030 | K190902 | 000 |
| 08500139037998 | K190902 | 000 |
| 00850013903771 | K190902 | 000 |
| 06972243188019 | K190902 | 000 |
| 06972243188149 | K190902 | 000 |
| 06972243188255 | K190902 | 000 |
| 06972243188279 | K190902 | 000 |
| 00856324008327 | K190902 | 000 |
| 00856324008334 | K190902 | 000 |
| 00856324008341 | K190902 | 000 |
| 00856324008358 | K190902 | 000 |
| 00856324008365 | K190902 | 000 |
| 10031262105933 | K190902 | 000 |