The following data is part of a premarket notification filed by Hmicro, Inc. with the FDA for Hmicro Wired C-patch Electrode, Trade Name Subject To Change.
| Device ID | K140096 |
| 510k Number | K140096 |
| Device Name: | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE |
| Classification | Electrode, Electrocardiograph |
| Applicant | HMICRO, INC. 4984 EL CAMINO REAL #200 Los Altos, CA 94022 |
| Contact | Kim Tompkins |
| Correspondent | Kim Tompkins HMICRO, INC. 4984 EL CAMINO REAL #200 Los Altos, CA 94022 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-14 |
| Decision Date | 2014-07-24 |
| Summary: | summary |