The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron 1250 High Frequency Electrosurgical Generator, Model A1250.
| Device ID | K001955 |
| 510k Number | K001955 |
| Device Name: | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | Richard Kozloff |
| Correspondent | Richard Kozloff AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-27 |
| Decision Date | 2000-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871020015 | K001955 | 000 |
| 10607151004634 | K001955 | 000 |
| 00607151050191 | K001955 | 000 |
| 00607151050207 | K001955 | 000 |
| 10884521035928 | K001955 | 000 |
| 10884521041622 | K001955 | 000 |
| 10884521041714 | K001955 | 000 |
| 10884521049727 | K001955 | 000 |
| 10884521546226 | K001955 | 000 |
| 10884521546233 | K001955 | 000 |
| 10607151006744 | K001955 | 000 |
| 10884521517417 | K001955 | 000 |
| 00192896009233 | K001955 | 000 |
| 00192896009301 | K001955 | 000 |
| 00815871020008 | K001955 | 000 |
| 10884521783843 | K001955 | 000 |