510(k) K162394
K162394 is an FDA 510(k) premarket notification submitted by Capintec, Inc. for the device "CRC-77tHR". The FDA issued a decision of Substantially Equivalent on March 8, 2017. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Capintec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2017
- Date Received
- August 26, 2016
- 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