510(k) K091255
K091255 is an FDA 510(k) premarket notification submitted by Minxray, Inc. for the device "MINXRAY, MODEL: BPD60". The FDA issued a decision of Substantially Equivalent on May 12, 2010. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Minxray, Inc. has 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2010
- Date Received
- Apr 29, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)