The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Barrx Halo 360 System, Model 1100c-115a.
| Device ID | K051168 |
| 510k Number | K051168 |
| Device Name: | BARRX HALO 360 SYSTEM, MODEL 1100C-115A |
| 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 | 2005-05-05 |
| Decision Date | 2005-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521189409 | K051168 | 000 |