Alarm Used W/Monitoring Spirometer

FDA 510(k) K792573 · Empire Plastics Manufacturer

Substantially Equivalent

510(k) numberK792573

Submission

Device name
Alarm Used W/Monitoring Spirometer
Applicant
Empire Plastics Manufacturer
Mchenry, IL, US
Received
December 13, 1979
Decision date
December 31, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code BZK

510(k)DeviceApplicantDecision
K192584BEACON Caresystem Model 00002144BZK · Traditional Mermaid Care A/S12/18/2019SE
K192595ExSpiron 2XiBZK · Special Respiratory Motion12/17/2019SE
K180788Gas Module 3BZK · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.10/24/2018SE
K173181ExSpiron 1XiBZK · Traditional Respiratory Motion, Inc.03/16/2018SE
K162131ExSpiron 1XiBZK · Traditional Respiratory Motion, Inc.05/09/2017SE
K130170Exspiron 1XIBZK · Special Respiratory Motion, Inc.05/29/2013SE
K120087ExspironBZK · Traditional Respiratory Motion, Inc.09/26/2012SE
K103578Philips NM3 Respiratory Monitor with VentassistBZK · Traditional Respironics Novametrix, LLC06/02/2011SE
K091853Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014BZK · Traditional Nspire Health, Inc.09/21/2009SE
K092217Mercury VCO2BZK · Special Respironics Novametrix, Inc.08/21/2009SE

More from Respironics Novametrix, Inc.

510(k)DeviceDecision
K792572Empire SpirometerBZK · Traditional 12/19/1979SE
K792571Counter UnitBWF · Traditional 12/19/1979SE
K790744Lung Function Amplifier ExerciserBWF · Traditional 04/27/1979SE

Questions and answers

When was Alarm Used W/Monitoring Spirometer cleared by the FDA?

Alarm Used W/Monitoring Spirometer (K792573) received a 510(k) decision of Substantially Equivalent on December 31, 1979, 18 days after the submission was received.

What is the product code of K792573?

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