Cleared Traditional

K853571 - MEDIPART SODA LIME MP-3522
(FDA 510(k) Clearance)

Oct 1985
Decision
64d
Days
Class 1
Risk

K853571 is an FDA 510(k) clearance for the MEDIPART SODA LIME MP-3522. This device is classified as a Absorbent, Carbon-dioxide (Class I - General Controls, product code CBL).

Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on October 29, 1985, 64 days after receiving the submission on August 26, 1985.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5300.

Submission Details

510(k) Number K853571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date October 29, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CBL — Absorbent, Carbon-dioxide
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5300