The following data is part of a premarket notification filed by Halt Medical Inc with the FDA for Halt 2000gi Electrosurgical Rf Ablation System Model Halt 2000gi.
| Device ID | K094009 |
| 510k Number | K094009 |
| Device Name: | HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HALT MEDICAL INC 131 SAND CREEK RD STE., B Brentwood, CA 94513 |
| Contact | Russ Delonzor |
| Correspondent | Russ Delonzor HALT MEDICAL INC 131 SAND CREEK RD STE., B Brentwood, CA 94513 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-28 |
| Decision Date | 2010-06-14 |
| Summary: | summary |