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510(k) K834129

Device
MEDELA APGAR TIMER
Applicant
MEDELA, INC.
510(k) number
K834129
Product code
LHB  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-10
Date received
1983-11-30
Regulation
880.2930
Classification name
Timer, Apgar
Medical specialty
General Hospital
Review panel
General Hospital
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 LHB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K811424ELECTRONIC APGAR TIMERPt&E1981-07-09

Legacy Summary#

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FDA Review#

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