CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20

Oximeter, Reprocessed

CLEAR MEDICAL, INC.

The following data is part of a premarket notification filed by Clear Medical, Inc. with the FDA for Clearmedical/nellcor Oxisensor Ii, Pediatric, Model D-20.

Pre-market Notification Details

Device IDK012622
510k NumberK012622
Device Name:CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
ClassificationOximeter, Reprocessed
Applicant CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue,  WA  98005
ContactRichard Radford
CorrespondentRichard Radford
CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue,  WA  98005
Product CodeNLF  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-13
Decision Date2002-07-03
Summary:summary

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