510(k) K940701
K940701 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH". The FDA issued a decision of Substantially Equivalent on April 28, 1994. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1994
- Date Received
- February 16, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1710
- Review Panel
- RA
- Submission Type