The following data is part of a premarket notification filed by Embla Systems with the FDA for Disposable Snap Electrode.
| Device ID | K172703 |
| 510k Number | K172703 |
| Device Name: | Disposable Snap Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Embla Systems 1 Hines Road, Suite 202 Kanata, CA K2k 3c7 |
| Contact | Sanjay Mehta |
| Correspondent | Sanjay Mehta Embla Systems 1 Hines Road, Suite 202 Kanata, CA K2k 3c7 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-07 |
| Decision Date | 2017-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830053938 | K172703 | 000 |
| 00382830025331 | K172703 | 000 |
| 00382830025263 | K172703 | 000 |