Cleared Traditional

K860147 - CARBON DIOXIDE ABSORBENTS
(FDA 510(k) Clearance)

Feb 1986
Decision
44d
Days
Class 1
Risk

K860147 is an FDA 510(k) clearance for the CARBON DIOXIDE ABSORBENTS. This device is classified as a Absorbent, Carbon-dioxide (Class I - General Controls, product code CBL).

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on February 28, 1986, 44 days after receiving the submission on January 15, 1986.

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

Submission Details

510(k) Number K860147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1986
Decision Date February 28, 1986
Days to Decision 44 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