510(k) K771180
K771180 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "GAMMA GOUNTING SYS., AUTO, MODEL 1400". The FDA issued a decision of Substantially Equivalent on Aug 3, 1977. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 1977
- Date Received
- Jun 30, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Counter (Beta, Gamma) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2320
- Review Panel
- CH
- Submission Type
- 510(k) Exempt