Cleared Traditional

K882017 - RESPIRONICS SUCTIONEASY (FDA 510(k) Clearance)

Jul 1988
Decision
62d
Days
Class 1
Risk

K882017 is an FDA 510(k) clearance for the RESPIRONICS SUCTIONEASY. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 14, 1988, 62 days after receiving the submission on May 13, 1988.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number K882017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1988
Decision Date July 14, 1988
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BSY — Catheters, Suction, Tracheobronchial
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.6810