The following data is part of a premarket notification filed by Wenzhou Kindcare Import & Export Co., Ltd with the FDA for Aneroid Sphygmomanometer, Model Kt-a01.
| Device ID | K081951 |
| 510k Number | K081951 |
| Device Name: | ANEROID SPHYGMOMANOMETER, MODEL KT-A01 |
| Classification | Blood Pressure Cuff |
| Applicant | WENZHOU KINDCARE IMPORT & EXPORT CO., LTD 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-09 |
| Decision Date | 2008-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814940020109 | K081951 | 000 |
| 06970784670147 | K081951 | 000 |
| 06970784670154 | K081951 | 000 |
| 06970784670161 | K081951 | 000 |
| 00084678920730 | K081951 | 000 |
| 06970784670048 | K081951 | 000 |
| 16970784670014 | K081951 | 000 |
| 16970784670007 | K081951 | 000 |
| 06970784670031 | K081951 | 000 |
| 06970784670062 | K081951 | 000 |
| 06970784670024 | K081951 | 000 |
| 06970784670017 | K081951 | 000 |
| 16970784670700 | K081951 | 000 |
| 06970784670700 | K081951 | 000 |
| 06970784670703 | K081951 | 000 |
| 06970784670130 | K081951 | 000 |