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 |