510(k) K934766
K934766 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "CARBON FIBER PALLET". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1994
- Date Received
- October 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Scintillation (Gamma)
- Device Class
- Class I
- Regulation Number
- 892.1100
- Review Panel
- RA
- Submission Type