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FDA 510(k)

COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)

K-Number: K121001 · 2012-04-17

ApplicantNovitas Medical, LLC
Decision Date2012-04-17
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) is the device name listed in this FDA 510(k) record. The listed applicant is Novitas Medical, LLC. It received FDA 510(k) clearance on 2012-04-17 under 510(k) number K121001. 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 COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)?

COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) is a medical device that received FDA 510(k) clearance on 2012-04-17. The listed applicant is Novitas Medical, LLC. The 510(k) number is K121001.

When did COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) receive FDA 510(k) clearance?

COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) received FDA 510(k) clearance on 2012-04-17, under 510(k) number K121001.

Who is the listed applicant for COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)?

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

What is the FDA product code for COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)?

The FDA product code for COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) 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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