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FDA 510(k)

Sequential Circulator SC-2004FC-OC

K-Number: K171793 · 2017-08-17

ApplicantBio Compression Systems, Inc.
Decision Date2017-08-17
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sequential Circulator SC-2004FC-OC is the device name listed in this FDA 510(k) record. The listed applicant is Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K171793. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sequential Circulator SC-2004FC-OC?

Sequential Circulator SC-2004FC-OC is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Bio Compression Systems, Inc.. The 510(k) number is K171793.

When did Sequential Circulator SC-2004FC-OC receive FDA 510(k) clearance?

Sequential Circulator SC-2004FC-OC received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171793.

Who is the listed applicant for Sequential Circulator SC-2004FC-OC?

The FDA 510(k) record lists Bio Compression Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sequential Circulator SC-2004FC-OC?

The FDA product code for Sequential Circulator SC-2004FC-OC is JOW.

Other records listing Bio Compression Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250974Bio Arterial Deluxe (IC-BAP-DX)K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLK210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLK180248VascuEase IC-1200-WH

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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