MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP

Calculator, Predicted Values, Pulmonary Function

PNEUMEDICS, INC.

The following data is part of a premarket notification filed by Pneumedics, Inc. with the FDA for Models Pb950 And Pb960 Dataloop And Spiroloop.

Pre-market Notification Details

Device IDK894667
510k NumberK894667
Device Name:MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
ClassificationCalculator, Predicted Values, Pulmonary Function
Applicant PNEUMEDICS, INC. 291 PEPE'S FRAM RD. Milford,  CT  06460
ContactP Imbruce
CorrespondentP Imbruce
PNEUMEDICS, INC. 291 PEPE'S FRAM RD. Milford,  CT  06460
Product CodeBTY  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-25
Decision Date1989-10-19

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