510(k) K863372
K863372 is an FDA 510(k) premarket notification submitted by Interspec, Inc. for the device "SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES". The FDA issued a decision of Substantially Equivalent on November 4, 1986. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Interspec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1986
- Date Received
- September 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Blood-Flow, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2120
- Review Panel
- CV
- Submission Type