FDA 510(k) Application Details - K001866

Device Classification Name	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia   More FDA Info for this Device
510(K) Number	K001866
Device Name	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Applicant	RADIOMETER MEDICAL A/S AKANDEVEJ 21 DK-2700 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	KRISTEN RONO Other 510(k) Applications for this Contact
Regulation Number	868.2500   More FDA Info for this Regulation Number
Classification Product Code	LPP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2000
Decision Date	12/07/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review