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510(k) K897107

Device
POLY G PHYSIOLOGICAL DATA RECORDER
Applicant
CNS, INC.
510(k) number
K897107
Product code
BXO  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-12
Date received
1989-12-21
Regulation
868.2900
Classification name
Transducer, Gas Pressure
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN F STOLTE
Address
7090 Shady Oak Rd. Eden Prairie MN US 55344 55344

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BXO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944027AG-839PA CO2 MODULE AND ACCESSORIESNihon Kohden America, Inc.1994-08-31

Legacy Summary#

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FDA Review#

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