Cleared Traditional

K873927 - REUSEABLE BREATHING TUBES
(FDA 510(k) Clearance)

Oct 1987
Decision
25d
Days
Class 1
Risk

K873927 is an FDA 510(k) clearance for the REUSEABLE BREATHING TUBES. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).

Submitted by Dryden Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 20, 1987, 25 days after receiving the submission on September 25, 1987.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K873927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1987
Decision Date October 20, 1987
Days to Decision 25 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BZO — Set, Tubing And Support, Ventilator (w Harness)
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5975