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510(k) K885079

Device
HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275
Applicant
MENNEN MEDICAL, INC.
510(k) number
K885079
Product code
LPP  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-17
Date received
1988-12-08
Regulation
868.2500
Classification name
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RONALD A WIDMAN
Address
10123 Main St. Clarence NY US 14031 14031

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LPP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001866TCM400Radiometer Medical A/S2000-12-07

Legacy Summary#

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FDA Review#

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