510(k) K974597
K974597 is an FDA 510(k) premarket notification submitted by Bayer Corp., Agfa Div. for the device "ADC COMPACT (AGFA DIAGNOSTIC CENTER)". The FDA issued a decision of Substantially Equivalent on March 9, 1998. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Bayer Corp., Agfa Div. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1998
- Date Received
- December 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type