Cleared Traditional

K864095 - ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
(FDA 510(k) Clearance)

K864095 · Gambro, Inc. · Anesthesiology device

Feb 1987

Decision

122d

Days

Class 1

Risk

K864095 is an FDA 510(k) clearance for the ENGSTROM EDITH MODELS 500,1000,1500 & 1500F. This device is classified as a Condenser, Heat And Moisture (artificial Nose) (Class I - General Controls, product code BYD).

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on February 20, 1987, 122 days after receiving the submission on October 21, 1986.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number	K864095 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 21, 1986
Decision Date	February 20, 1987
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—