510(k) K915541
K915541 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "SPECT TABLE, MODEL #056-760". The FDA issued a decision of Substantially Equivalent on January 17, 1992. The device falls under product code IYZ (Bed, Scanning, Nuclear), a Class I device regulated under 21 CFR 892.1350. Atomic Products Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1992
- Date Received
- December 10, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Scanning, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1350
- Review Panel
- RA
- Submission Type