510(k) K790168
K790168 is an FDA 510(k) premarket notification submitted by Cmsi for the device "COLLIMATOR, BILATERIAL". The FDA issued a decision of Substantially Equivalent on February 15, 1979. The device falls under product code KQA (Device, Beam Limiting, X-Ray, Therapeutic), a Class II device regulated under 21 CFR 892.5900. Cmsi has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 1979
- Date Received
- January 23, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Beam Limiting, X-Ray, Therapeutic
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type