The following data is part of a premarket notification filed by Encision, Inc. with the FDA for Aem Monitoring System, Models Em2, Emr, Es4007, Es4107, Es9005 And Es9015.
| Device ID | K093622 |
| 510k Number | K093622 |
| Device Name: | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Contact | Judith V King |
| Correspondent | Judith V King 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 | 2009-11-23 |
| Decision Date | 2010-08-20 |
| Summary: | summary |