510(k) K881303
K881303 is an FDA 510(k) premarket notification submitted by Triton Technology, Inc. for the device "TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER". The FDA issued a decision of Substantially Equivalent on Nov 29, 1988. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Triton Technology, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 29, 1988
- Date Received
- Mar 28, 1988
- 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
- 510(k)