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FDA 510(k)

MODEL 700

K-Number: K944180 · 1997-03-07

ApplicantMemtec Corp.
Decision Date1997-03-07
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 700 is the device name listed in this FDA 510(k) record. The listed applicant is Memtec Corp.. It received FDA 510(k) clearance on 1997-03-07 under 510(k) number K944180. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 700?

MODEL 700 is a medical device that received FDA 510(k) clearance on 1997-03-07. The listed applicant is Memtec Corp.. The 510(k) number is K944180.

When did MODEL 700 receive FDA 510(k) clearance?

MODEL 700 received FDA 510(k) clearance on 1997-03-07, under 510(k) number K944180.

Who is the listed applicant for MODEL 700?

The FDA 510(k) record lists Memtec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 700?

The FDA product code for MODEL 700 is DSH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Memtec Corp. 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.

K103427MOBILEECG SYSTEMK102723MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens 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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