AIROS 8 Sequential Compression Device

Sleeve, Limb, Compressible

AIROS Medical, Inc.

The following data is part of a premarket notification filed by Airos Medical, Inc. with the FDA for Airos 8 Sequential Compression Device.

Pre-market Notification Details

Device IDK193068
510k NumberK193068
Device Name:AIROS 8 Sequential Compression Device
ClassificationSleeve, Limb, Compressible
Applicant AIROS Medical, Inc. 2501 Monroe Blvd. Suite 1200 Audubon,  PA  19403
ContactDarren Behuniak
CorrespondentDarren Behuniak
AIROS Medical, Inc. 2501 Monroe Blvd. Suite 1200 Audubon,  PA  19403
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-04
Decision Date2019-12-04

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