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510(k) K983274

Device
STARTRACK INFANT GRAPHICS MONITOR
Applicant
NELLCOR PURITAN BENNETT, INC.
510(k) number
K983274
Product code
BZK  
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-09
Date received
1998-09-17
Regulation
868.1850
Classification name
Spirometer, Monitoring (w/wo Alarm)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID A.C. GREEN
Address
11150 Thompson Ave. Lenexa KS US 66219 66219

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BZK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192584BEACON Caresystem Model 00002144Mermaid Care A/S2019-12-18
K192595ExSpiron 2XiRespiratory Motion2019-12-17
K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-10-24
K173181ExSpiron 1XiRespiratory Motion, Inc.2018-03-16
K162131ExSpiron 1XiRespiratory Motion, Inc.2017-05-09
K130170EXSPIRON 1XIRespiratory Motion, Inc.2013-05-29
K120087EXSPIRONRespiratory Motion, Inc.2012-09-26
K103578PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSISTRespironics Novametrix, LLC2011-06-02
K091853WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014Nspire Health, Inc.2009-09-21
K092217MERCURY VCO2Respironics Novametrix, Inc.2009-08-21
K091459PHILIPS NM3 MONITOR, MODEL 7900Respironics Novametrix, LLC2009-07-28
K080652MERCURY VCO2 MODULE WITH CAPNOSTAT 5Respironics Novametrix, LLC2008-06-20
K062754GAS MODULE SE, MODEL 0998-00-0481-02Datascope Corp.2006-11-02
K051279CALDYNE, INC. EXHALOMETER EX100, MODEL EX100Caldyne, Inc.2005-09-07
K972086ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311Alexander Mfg. Co.1997-08-12

Legacy Summary#

summary

FDA Review#

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