510(k) K042258
K042258 is an FDA 510(k) premarket notification submitted by Syntermed, Inc. for the device "BP-SPECT V1.O". The FDA issued a decision of Substantially Equivalent on Oct 4, 2004. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Syntermed, Inc. has 13 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 4, 2004
- Date Received
- Aug 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
- 510(k)