510(k) K920793
K920793 is an FDA 510(k) premarket notification submitted by Philips Medical Systems, Inc. for the device "PHILIPS DSI SYSTEM RELEASE 3.2". The FDA issued a decision of Substantially Equivalent on July 17, 1992. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Philips Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1992
- Date Received
- February 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, X-Ray, Fluorographic, Cine Or Spot
- Device Class
- Class II
- Regulation Number
- 892.1620
- Review Panel
- RA
- Submission Type