510(k) K935539
K935539 is an FDA 510(k) premarket notification submitted by Capintec Instruments, Inc. for the device "CAPINTEC CRC 35R". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Capintec Instruments, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1994
- Date Received
- November 16, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Dose, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.1360
- Review Panel
- RA
- Submission Type