AIROS 6 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 6 Sequential Compression Device.

Pre-market Notification Details

Device IDK172770
510k NumberK172770
Device Name:AIROS 6 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-14
Decision Date2018-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10855682007154 K172770 000
10855682007048 K172770 000
10855682007055 K172770 000
10855682007062 K172770 000
10855682007079 K172770 000
10855682007086 K172770 000
10855682007093 K172770 000
10855682007109 K172770 000
10855682007116 K172770 000
10855682007123 K172770 000
10855682007130 K172770 000
10855682007147 K172770 000
00855682007010 K172770 000

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