The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Voyant Electrosurgical Generator.
Device ID | K182244 |
510k Number | K182244 |
Device Name: | Voyant Electrosurgical Generator |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
Contact | Andrew Nguyen |
Correspondent | Andrew Nguyen Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-20 |
Decision Date | 2018-10-11 |
Summary: | summary |