The following data is part of a premarket notification filed by Advanced Instrument Development, Inc. with the FDA for Mobil-aid Automatic Exposure Control.
Device ID | K813128 |
510k Number | K813128 |
Device Name: | MOBIL-AID AUTOMATIC EXPOSURE CONTROL |
Classification | System, X-ray, Mobile |
Applicant | ADVANCED INSTRUMENT DEVELOPMENT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-05 |
Decision Date | 1981-12-03 |