Vacu*med, Gold Edition Carbon Dioxide Gas Analyzer

by Vacumed, Div. of Vacumetrics, Inc. 510(k)

Active United States

510(k) K973544

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK973544	Date26 May 1998Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K973544
FDA Product Code: CCK

Device Class: Class II
Regulation: 21 CFR Part 868.1400
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

Other devices from Vacumed, Div. of Vacumetrics, Inc.

Vacu*med Gold Edition Oxygen Gas Analyzer

Class II