510(k) K781065
K781065 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "PLURIMAT;RADIOGRAPHIC TUBE MOUNT". The FDA issued a decision of Substantially Equivalent on Jul 17, 1978. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Tecnomed, Inc. has 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 17, 1978
- Date Received
- Jun 26, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Mount, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1770
- Review Panel
- RA
- Submission Type
- 510(k) Exempt