510(k) K904187
K904187 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "ECONOMY C-ARM TABLE, MODEL # 056-005". The FDA issued a decision of Substantially Equivalent on November 29, 1990. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Atomic Products Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1990
- Date Received
- September 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Radiographic, Stationary Top
- Device Class
- Class II
- Regulation Number
- 892.1980
- Review Panel
- RA
- Submission Type