The following data is part of a premarket notification filed by Novasys Medical, Inc. with the FDA for Ariel Radio Frequency (rf) Electrosurgical Control Module And Accessories.
| Device ID | K013730 |
| 510k Number | K013730 |
| Device Name: | ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Contact | Thomas C Wehman |
| Correspondent | Thomas C Wehman NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-09 |
| Decision Date | 2002-02-06 |
| Summary: | summary |