K903012 is an FDA 510(k) clearance for the AUDIOPRAT ENDOSCOPE. This device is classified as a Collimator, X-ray (Class I - General Controls, product code EHB).
Submitted by S.C.D.P.I. of Florida, Inc. (Ormond Beach, US). The FDA issued a Cleared decision on October 9, 1990, 90 days after receiving the submission on July 11, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1840.
| 510(k) Number | K903012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1990 |
| Decision Date | October 09, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | EHB — Collimator, X-ray |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.1840 |