510(k) K841905
K841905 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "DOT-A, DOT-AR PXP-E, PXP-ER". The FDA issued a decision of Substantially Equivalent on August 9, 1984. The device falls under product code JWM (System, Tomographic, Nuclear), a Class II device regulated under 21 CFR 892.1310. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 1984
- Date Received
- May 7, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomographic, Nuclear
- Device Class
- Class II
- Regulation Number
- 892.1310
- Review Panel
- RA
- Submission Type