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510(k) K001866

Device
TCM400
Applicant
RADIOMETER MEDICAL A/S
510(k) number
K001866
Product code
LPP  
Decision
Substantially Equivalent (SESE)
Decision date
2000-12-07
Date received
2000-06-20
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KRISTEN RONO
Address
Akandevej 21 Dk-2700 Bronshoj DK

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LPP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K885079HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275Mennen Medical, Inc.1989-02-17

Legacy Summary#

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FDA Review#

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