510(k) K925332
K925332 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Technologies for the device "BENNETT X-RAY ID PLUS". The FDA issued a decision of Substantially Equivalent on November 27, 1992. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640. Bennett X-Ray Technologies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 1992
- Date Received
- October 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Film Marking, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1640
- Review Panel
- RA
- Submission Type