The following data is part of a premarket notification filed by Gmc Inc. with the FDA for Gmc Wrist Automatic Blood Pressure Monitor.
| Device ID | K181930 |
| 510k Number | K181930 |
| Device Name: | GMC Wrist Automatic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GMC Inc. No. 686, Su Chu Rd. Chuzhou, CN 239000 |
| Contact | Yolanda Li |
| Correspondent | Yolanda Li GMC Inc. No. 686, Su Chu Rd. Chuzhou, CN 239000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-18 |
| Decision Date | 2019-02-14 |
| Summary: | summary |