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510(k) K944027

Device
AG-839PA CO2 MODULE AND ACCESSORIES
Applicant
NIHON KOHDEN AMERICA, INC.
510(k) number
K944027
Product code
BXO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-31
Date received
1994-08-17
Regulation
868.2900
Classification name
Transducer, Gas Pressure
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PENNI PANNELL
Address
2601 Campus Dr. Irvine CA US 92612 92612

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BXO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K897107POLY G PHYSIOLOGICAL DATA RECORDERCns, Inc.1990-03-12

Legacy Summary#

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FDA Review#

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