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510(k) K801050

Device
SUPRA SCOPE
Applicant
WARNER-LAMBERT CO.
510(k) number
K801050
Product code
BZS  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-14
Date received
1980-05-05
Regulation
868.1930
Classification name
Stethoscope Head
Medical specialty
Anesthesiology
Review panel
Anesthesiology
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 BZS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935146DISPOSABLE STETHOSCOPE HEAD COVERModern Medical Devices, Inc.1994-07-11
K930118STETSKINSNova Diversified Concepts1993-03-26

Legacy Summary#

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FDA Review#

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