Cleared Traditional

K873447 - DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (FDA 510(k) Clearance)

Oct 1987
Decision
74d
Days
Class 1
Risk

K873447 is an FDA 510(k) clearance for the DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR. This device is classified as a Drain, Tee (water Trap) (Class I - General Controls, product code BYH).

Submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on October 30, 1987, 74 days after receiving the submission on August 17, 1987.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5995.

Submission Details

510(k) Number K873447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date October 30, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

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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