The following data is part of a premarket notification filed by Geiger Medical Technologies, Inc. with the FDA for Thermal Cautery Unit, Model 150.
| Device ID | K002341 |
| 510k Number | K002341 |
| Device Name: | THERMAL CAUTERY UNIT, MODEL 150 |
| Classification | Unit, Cautery, Thermal, Ac-powered |
| Applicant | GEIGER MEDICAL TECHNOLOGIES, INC. 24040 CAMINO DEL AVION, A-195 Monarch Beach, CA 92629 |
| Contact | John Bottjer |
| Correspondent | John Bottjer GEIGER MEDICAL TECHNOLOGIES, INC. 24040 CAMINO DEL AVION, A-195 Monarch Beach, CA 92629 |
| Product Code | HQO |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2000-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00609960001128 | K002341 | 000 |
| 00609960001111 | K002341 | 000 |
| 00609960000817 | K002341 | 000 |
| 00609960000800 | K002341 | 000 |
| 00609960000794 | K002341 | 000 |
| 00609960000787 | K002341 | 000 |