510(k) K760595
K760595 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "CARDIAC PROBE". The FDA issued a decision of Substantially Equivalent on Sep 17, 1976. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 17, 1976
- Date Received
- Sep 7, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Probe, Uptake, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1320
- Review Panel
- RA
- Submission Type
- 510(k) Exempt