Cleared Traditional

K893714 - KEYSTONE OXYGEN TENT (FDA 510(k) Clearance)

K893714 · Keystone Veterinary Supplies, Inc. · Anesthesiology device

Aug 1989

Decision

95d

Days

Class 1

Risk

K893714 is an FDA 510(k) clearance for the KEYSTONE OXYGEN TENT. This device is classified as a Tent, Oxygen (Class I - General Controls, product code BYL).

Submitted by Keystone Veterinary Supplies, Inc. (Blackwood, US). The FDA issued a Cleared decision on August 21, 1989, 95 days after receiving the submission on May 18, 1989.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.

Submission Details

510(k) Number	K893714 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 18, 1989
Decision Date	August 21, 1989
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—