FDA.reportPublic FDA data

510(k) K781501

Device
Enzac Incubator
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K781501
Product code
JRG
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-03
Date received
1978-08-30
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
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

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
K823766BLOOD GAS INCUBATOR #260650Boekel Industries, Inc.1983-02-18
K790549HEATING BLOCK, WAMPOLE 37 CArmkel, LLC1979-05-03