510(k) K812893
K812893 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "SUPERFLAB". The FDA issued a decision of Substantially Equivalent on December 8, 1981. The device falls under product code IYP (Phantom, Anthropomorphic, Nuclear), a Class I device regulated under 21 CFR 892.1370. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1981
- Date Received
- October 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phantom, Anthropomorphic, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1370
- Review Panel
- RA
- Submission Type