The following data is part of a premarket notification filed by Advanced Instrument Development, Inc. with the FDA for Power-aid Independent X-ray Power Source.
Device ID | K872445 |
510k Number | K872445 |
Device Name: | POWER-AID INDEPENDENT X-RAY POWER SOURCE |
Classification | Generator, High-voltage, X-ray, Diagnostic |
Applicant | ADVANCED INSTRUMENT DEVELOPMENT, INC. 1011 NORTH 25TH AVE. Melrose Park, IL 60160 |
Contact | Lyle E Packard |
Correspondent | Lyle E Packard ADVANCED INSTRUMENT DEVELOPMENT, INC. 1011 NORTH 25TH AVE. Melrose Park, IL 60160 |
Product Code | IZO |
CFR Regulation Number | 892.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-23 |
Decision Date | 1987-08-12 |