510(k) K903012
K903012 is an FDA 510(k) premarket notification submitted by S.C.D.P.I. of Florida, Inc. for the device "AUDIOPRAT ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on October 9, 1990. The device falls under product code EHB (Collimator, X-Ray), a Class I device regulated under 21 CFR 872.1840.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1990
- Date Received
- July 11, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1840
- Review Panel
- RA
- Submission Type