510(k) K913243
K913243 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE". The FDA issued a decision of Substantially Equivalent on September 19, 1991. The device falls under product code IXG (Phantom, Anthropomorphic, Radiographic), a Class I device regulated under 21 CFR 892.1950. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1991
- Date Received
- July 22, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phantom, Anthropomorphic, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1950
- Review Panel
- RA
- Submission Type