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510(k) K823766

Device
BLOOD GAS INCUBATOR #260650
Applicant
BOEKEL INDUSTRIES, INC.
510(k) number
K823766
Product code
JRG  
Decision
Substantially Equivalent (SESE)
Decision date
1983-02-18
Date received
1982-12-14
Regulation
862.2050
Classification name
Block, Heating
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JRG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K790549HEATING BLOCK, WAMPOLE 37 CArmkel, LLC1979-05-03
K781501ENZAC INCUBATORBd Becton Dickinson Vacutainer Systems Preanalytic1978-10-03

Legacy Summary#

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FDA Review#

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