The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Haloflex Energy Generator, Models 1190a-115a And 1190a-230a.
| Device ID | K092487 |
| 510k Number | K092487 |
| Device Name: | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale, CA 94085 |
| Contact | Viorica Filimon |
| Correspondent | Viorica Filimon BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale, CA 94085 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-13 |
| Decision Date | 2009-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521177796 | K092487 | 000 |
| 10884521660694 | K092487 | 000 |
| 10884521823624 | K092487 | 000 |