The following data is part of a premarket notification filed by S.c.d.p.i. Of Florida, Inc. with the FDA for Audioprat Endoscope.
| Device ID | K903012 |
| 510k Number | K903012 |
| Device Name: | AUDIOPRAT ENDOSCOPE |
| Classification | Collimator, X-ray |
| Applicant | S.C.D.P.I. OF FLORIDA, INC. 256 N. NOVA ROAD, SUITE 38 Ormond Beach, FL 32174 |
| Contact | Claude D Berthoin |
| Correspondent | Claude D Berthoin S.C.D.P.I. OF FLORIDA, INC. 256 N. NOVA ROAD, SUITE 38 Ormond Beach, FL 32174 |
| Product Code | EHB |
| CFR Regulation Number | 872.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-10-09 |