BENCHMARK TRANSFER TEST

Calculator, Pulmonary Function Data

P.K. MORGAN LTD.

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

Pre-market Notification Details

Device IDK954730
510k NumberK954730
Device Name:BENCHMARK TRANSFER TEST
ClassificationCalculator, Pulmonary Function Data
Applicant P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed,  GB
ContactR. H Jkernaghan
CorrespondentR. H Jkernaghan
P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed,  GB
Product CodeBZC  
CFR Regulation Number868.1880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-16
Decision Date1997-04-01

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