The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron 1200 High Frequency Electrosurgical Generator, Model A1200 Aaron 1200 High Frequency Electrosurgical Generator Mod.
Device ID | K981570 |
510k Number | K981570 |
Device Name: | AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
Contact | Rob Saron |
Correspondent | Rob Saron 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 | 1998-05-04 |
Decision Date | 1998-09-14 |
Summary: | summary |