510(k) K923141
K923141 is an FDA 510(k) premarket notification submitted by Philips Medical Systems, Inc. for the device "PHILIPS PRE-FILTER OPTION". The FDA issued a decision of Substantially Equivalent on January 21, 1993. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Philips Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1993
- Date Received
- June 29, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assembly, Tube Housing, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1760
- Review Panel
- RA
- Submission Type