510(k) K990423
K990423 is an FDA 510(k) premarket notification submitted by Philips Medical Systems, Inc. for the device "PHILIPS NICOL COLLIMATOR FAMILY". The FDA issued a decision of Substantially Equivalent on Mar 15, 1999. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Philips Medical Systems, Inc. has 220 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 1999
- Date Received
- Feb 11, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, Automatic, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type
- 510(k) Exempt