510(k) K895799
K895799 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "RECTILINEAR SCANNER MODEL #187-270". The FDA issued a decision of Substantially Equivalent on February 1, 1990. The device falls under product code IYW (Scanner, Rectilinear, Nuclear), a Class I device regulated under 21 CFR 892.1300. Atomic Products Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1990
- Date Received
- September 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Rectilinear, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1300
- Review Panel
- RA
- Submission Type