510(k) K953513
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1995
- Date Received
- July 26, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Rebreathing, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.1390
- Review Panel
- RA
- Submission Type