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FDA 510(k)

SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)

K-Number: K003701 · 2001-04-05

ApplicantSentech Medical Systems, Inc.
Decision Date2001-04-05
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) is the device name listed in this FDA 510(k) record. The listed applicant is Sentech Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K003701. 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 SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)?

SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Sentech Medical Systems, Inc.. The 510(k) number is K003701.

When did SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) receive FDA 510(k) clearance?

SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) received FDA 510(k) clearance on 2001-04-05, under 510(k) number K003701.

Who is the listed applicant for SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)?

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

What is the FDA product code for SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)?

The FDA product code for SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) is JOW.

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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

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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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