Sleepware G3

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Respironics, Inc.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Sleepware G3.

Pre-market Notification Details

Device IDK202142
510k NumberK202142
Device Name:Sleepware G3
ClassificationAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant Respironics, Inc. 1001 Murry Ridge Lane Murrysville,  PA  15668
ContactJonquil Mau
CorrespondentJonquil Mau
Respironics, Inc. 1001 Murry Ridge Lane Murrysville,  PA  15668
Product CodeOLZ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2020-10-29

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