The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Dtv-4114 Fluoroscopic Television Camera.
Device ID | K881688 |
510k Number | K881688 |
Device Name: | DTV-4114 FLUOROSCOPIC TELEVISION CAMERA |
Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Gary L Pembroke |
Correspondent | Gary L Pembroke ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Product Code | IZJ |
CFR Regulation Number | 892.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-19 |
Decision Date | 1988-05-18 |