510(k) K954564
K954564 is an FDA 510(k) premarket notification submitted by Gammex, Inc. for the device "PID-1 PRECISION INTELLIGENT DOSIMETER". The FDA issued a decision of Substantially Equivalent on April 22, 1996. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Gammex, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1996
- Date Received
- October 2, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type