Spirometer, Therapeutic (incentive)

Respinova Ltd.

The following data is part of a premarket notification filed by Respinova Ltd. with the FDA for Pulsehaler.

Pre-market Notification Details

Device IDK203378
510k NumberK203378
Device Name:Pulsehaler
ClassificationSpirometer, Therapeutic (incentive)
Applicant Respinova Ltd. Hachoshlim 8 Herzliya,  IL 4672408
ContactCliff Ansel
CorrespondentJoel Ironstone
Ironstone Product Development Inc. 250 Carlaw Avenue Suite 108 Toronto,  CA M4m 3l1
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-17
Decision Date2021-03-31

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