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FDA 510(k)

CARDIOVIEW TRANSTELEPHONIC SOFTWARE

K-Number: K955891 · 1996-10-08

ApplicantMicromedical, Inc.
Decision Date1996-10-08
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVIEW TRANSTELEPHONIC SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical, Inc.. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K955891. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVIEW TRANSTELEPHONIC SOFTWARE?

CARDIOVIEW TRANSTELEPHONIC SOFTWARE is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Micromedical, Inc.. The 510(k) number is K955891.

When did CARDIOVIEW TRANSTELEPHONIC SOFTWARE receive FDA 510(k) clearance?

CARDIOVIEW TRANSTELEPHONIC SOFTWARE received FDA 510(k) clearance on 1996-10-08, under 510(k) number K955891.

Who is the listed applicant for CARDIOVIEW TRANSTELEPHONIC SOFTWARE?

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

What is the FDA product code for CARDIOVIEW TRANSTELEPHONIC SOFTWARE?

The FDA product code for CARDIOVIEW TRANSTELEPHONIC SOFTWARE is DPS.

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 Micromedical, 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.

K974352CARDIOVIEW 3000 SOFTWAREK974220MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEK974351BIOLOG 3000 ELECTROCARDIOGRAPHK970305PRINTER INTERFACE

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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