The following data is part of a premarket notification filed by Famidoc Technology Company Limited with the FDA for Upper Arm Blood Pressure Monitor.
| Device ID | K191673 |
| 510k Number | K191673 |
| Device Name: | Upper Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Famidoc Technology Company Limited No. 212 Yilong Road, Hexi Industrial Zone Jinxia, Changan Town Dongguan, CN 523853 |
| Contact | Leon Cao |
| Correspondent | Leon Cao Famidoc Technology Company Limited No. 212 Yilong Road, Hexi Industrial Zone Jinxia, Changan Town Dongguan, CN 523853 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-24 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818218023014 | K191673 | 000 |
| 06970389638160 | K191673 | 000 |
| 06970389638153 | K191673 | 000 |
| 06970389638146 | K191673 | 000 |
| 06970389638122 | K191673 | 000 |
| 06970389638108 | K191673 | 000 |
| 06970389638092 | K191673 | 000 |
| 06970389638085 | K191673 | 000 |
| 06970389638078 | K191673 | 000 |
| 06970389638061 | K191673 | 000 |
| 06970389632335 | K191673 | 000 |
| 06970389638177 | K191673 | 000 |
| 06970389638184 | K191673 | 000 |
| 00031262107046 | K191673 | 000 |
| 00628176949567 | K191673 | 000 |
| 06970389638559 | K191673 | 000 |
| 06970389638443 | K191673 | 000 |
| 06970389638252 | K191673 | 000 |
| 06970389638238 | K191673 | 000 |
| 06970389638221 | K191673 | 000 |
| 06970389638214 | K191673 | 000 |
| 06970389638207 | K191673 | 000 |
| 06970389638191 | K191673 | 000 |
| 06970389631130 | K191673 | 000 |