Cleared Traditional

K771246 - ALARM SYS FOR NITROUS OXIDE SYS.
(FDA 510(k) Clearance)

K771246 · Star Dental Mfg. Co. · Anesthesiology

Jul 1977

Decision

Days

Class 1

Risk

K771246 is an FDA 510(k) clearance for the ALARM SYS FOR NITROUS OXIDE SYS.. This device is classified as a Cylinder, Compressed Gas, And Valve (Class I — General Controls, product code ECX).

Submitted by Star Dental Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1977, 4 days after receiving the submission on July 11, 1977.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K771246 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 1977
Decision Date	July 15, 1977
Days to Decision	4 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—