510(k) K924593
K924593 is an FDA 510(k) premarket notification submitted by Philips Medical Systems, Inc. for the device "DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4". The FDA issued a decision of Substantially Equivalent on November 24, 1992. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Philips Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1992
- Date Received
- September 10, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Spot-Film
- Device Class
- Class II
- Regulation Number
- 892.1670
- Review Panel
- RA
- Submission Type