510(k) K781675
K781675 is an FDA 510(k) premarket notification submitted by General X-Ray, Inc. for the device "X-RAY COLLIMATOR". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code EHB (Collimator, X-Ray), a Class I device regulated under 21 CFR 872.1840. General X-Ray, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1978
- Date Received
- September 29, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1840
- Review Panel
- RA
- Submission Type