510(k) K974112
K974112 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "VACUDAP, MODEL 2000, 2001". The FDA issued a decision of Substantially Equivalent on January 29, 1998. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Victoreen, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1998
- Date Received
- October 31, 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