510(k) K042746
K042746 is an FDA 510(k) premarket notification submitted by Comecer S.R.L. for the device "PET-DOSE". The FDA issued a decision of Substantially Equivalent on November 22, 2004. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2004
- Date Received
- October 4, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Calibrator, Dose, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.1360
- Review Panel
- RA
- Submission Type