The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010; Footswitch, Model 90-9020.
| Device ID | K062441 |
| 510k Number | K062441 |
| Device Name: | BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BARRX MEDICAL, INCORPORATED 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BARRX MEDICAL, INCORPORATED 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2006-11-14 |
| Summary: | summary |