510(k) K772313
K772313 is an FDA 510(k) premarket notification submitted by Rinn Corp. for the device "X-RAY CO-ORDINATOR". The FDA issued a decision of Substantially Equivalent on January 30, 1978. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. Rinn Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1978
- Date Received
- December 12, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Head, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1920
- Review Panel
- RA
- Submission Type