Mercury VCO2

FDA 510(k) K092217 · Respironics Novametrix, Inc.

Substantially Equivalent

510(k) numberK092217

Submission

Device name
Mercury VCO2
Applicant
Respironics Novametrix, Inc.
Wallingford, CT, US
Received
July 22, 2009
Decision date
August 21, 2009
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZK – Spirometer, Monitoring (W/Wo Alarm)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1850
Specialty
Anesthesiology

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More from Respironics Novametrix, LLC

510(k)DeviceDecision
K103578Philips NM3 Respiratory Monitor with VentassistBZK · Traditional 06/02/2011SE
K091459Philips NM3 Monitor, Model 7900BZK · Special 07/28/2009SE
K080652Mercury VCO2 Module with Capnostat 5BZK · Special 06/20/2008SE
K053174Loflo C5 CO2 SensorCCK · Special 01/12/2006SE
K042601Capnostat 5CCK · Special 11/19/2004SE
K032971Tidal Wave SP Model 710/715 and 715DQA · Traditional 08/26/2004SE
K032949Spot Check Pulse OXIMETER,512/513DQA · Traditional 08/23/2004SE
K041450Modification to Nico with Mars, Model 7300CCK · Special 06/18/2004SE
K032755Model 509M Pulse Oximeter, Model 509MDQA · Traditional 05/21/2004SE
K030886Nico with Mars, Model 7300CCK · Traditional 10/07/2003SE

Questions and answers

When was Mercury VCO2 cleared by the FDA?

Mercury VCO2 (K092217) received a 510(k) decision of Substantially Equivalent on August 21, 2009, 30 days after the submission was received.

What is the product code of K092217?

The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.