510(k) K780855
K780855 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "GAMMA CAMERA". The FDA issued a decision of Substantially Equivalent on Jun 2, 1978. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 1978
- Date Received
- May 19, 1978
- 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
- 510(k)