Cleared Traditional

AQUALARM MOISTURE SENSOR MODEL P85000

K946057 · Pegasus Research Corp. · Anesthesiology
May 1995
Decision
144d
Days
Class 1
Risk

About This 510(k) Submission

K946057 is an FDA 510(k) clearance for the AQUALARM MOISTURE SENSOR MODEL P85000, a Drain, Tee (water Trap) (Class I — General Controls, product code BYH), submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on May 5, 1995, 144 days after receiving the submission on December 12, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5995.

Submission Details

510(k) Number K946057 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1994
Decision Date May 05, 1995
Days to Decision 144 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYH — Drain, Tee (water Trap)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5995

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