The following data is part of a premarket notification filed by Encision, Inc. with the FDA for Em3 Aem Monitor Aem Connectors.
| Device ID | K122383 |
| 510k Number | K122383 |
| Device Name: | EM3 AEM MONITOR AEM CONNECTORS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Contact | Jim Lewis |
| Correspondent | Jim Lewis ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2013-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815288014154 | K122383 | 000 |
| 10815288014147 | K122383 | 000 |
| 10815288014161 | K122383 | 000 |