Cleared Traditional

TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER

K881303 · Triton Technology, Inc. · Cardiovascular
Nov 1988
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K881303 is an FDA 510(k) clearance for the TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER, a Probe, Blood-flow, Extravascular (Class II — Special Controls, product code DPT), submitted by Triton Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on November 29, 1988, 246 days after receiving the submission on March 28, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2120.

Submission Details

510(k) Number K881303 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1988
Decision Date November 29, 1988
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DPT — Probe, Blood-flow, Extravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2120

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