510(k) K842895
K842895 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "WBA - I.R.I.S.". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code JAM (Scanner, Whole Body, Nuclear), a Class I device regulated under 21 CFR 892.1330. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1984
- Date Received
- July 23, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Whole Body, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1330
- Review Panel
- RA
- Submission Type