510(k) K885126
K885126 is an FDA 510(k) premarket notification submitted by Perkins Mfg. Co. for the device "PHILIPS RT250 COLLIMATOR (PK8050)". The FDA issued a decision of Substantially Equivalent on June 1, 1989. The device falls under product code KQA (Device, Beam Limiting, X-Ray, Therapeutic), a Class II device regulated under 21 CFR 892.5900. Perkins Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1989
- Date Received
- December 12, 1988
- 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