OXYLOG 2

Computer, Oxygen-uptake

P.K. MORGAN LTD.

The following data is part of a premarket notification filed by P.k. Morgan Ltd. with the FDA for Oxylog 2.

Pre-market Notification Details

Device IDK954731
510k NumberK954731
Device Name:OXYLOG 2
ClassificationComputer, Oxygen-uptake
Applicant P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed,  GB
ContactR. H Kernaghan
CorrespondentR. H Kernaghan
P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed,  GB
Product CodeBZL  
CFR Regulation Number868.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-16
Decision Date1997-01-06

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