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FDA 510(k)

MODEL SC-3008 SEQUENTIAL CIRCULATOR

K-Number: K043423 · 2005-02-01

ApplicantBio Compression Systems, Inc.
Decision Date2005-02-01
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SC-3008 SEQUENTIAL CIRCULATOR 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 2005-02-01 under 510(k) number K043423. 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 MODEL SC-3008 SEQUENTIAL CIRCULATOR?

MODEL SC-3008 SEQUENTIAL CIRCULATOR is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Bio Compression Systems, Inc.. The 510(k) number is K043423.

When did MODEL SC-3008 SEQUENTIAL CIRCULATOR receive FDA 510(k) clearance?

MODEL SC-3008 SEQUENTIAL CIRCULATOR received FDA 510(k) clearance on 2005-02-01, under 510(k) number K043423.

Who is the listed applicant for MODEL SC-3008 SEQUENTIAL CIRCULATOR?

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 MODEL SC-3008 SEQUENTIAL CIRCULATOR?

The FDA product code for MODEL SC-3008 SEQUENTIAL CIRCULATOR is JOW.

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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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)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-WHK171793Sequential Circulator SC-2004FC-OC

View all 14 devices →

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® 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.

Official Source

View on FDA Database →

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

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