510(k) K834465
K834465 is an FDA 510(k) premarket notification submitted by Cirs, Inc. for the device "SERIES OF DIAGNOSTIC PHANTOMS". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code IXG (Phantom, Anthropomorphic, Radiographic), a Class I device regulated under 21 CFR 892.1950.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1984
- Date Received
- December 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phantom, Anthropomorphic, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1950
- Review Panel
- RA
- Submission Type