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FDA 510(k)

ZYMED TELEMETRY SYSTEM; MODEL T8010

K-Number: K951370 · 1995-10-06

ApplicantZymed Medical Instrumentation
Decision Date1995-10-06
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZYMED TELEMETRY SYSTEM; MODEL T8010 is the device name listed in this FDA 510(k) record. The listed applicant is Zymed Medical Instrumentation. It received FDA 510(k) clearance on 1995-10-06 under 510(k) number K951370. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYMED TELEMETRY SYSTEM; MODEL T8010?

ZYMED TELEMETRY SYSTEM; MODEL T8010 is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is Zymed Medical Instrumentation. The 510(k) number is K951370.

When did ZYMED TELEMETRY SYSTEM; MODEL T8010 receive FDA 510(k) clearance?

ZYMED TELEMETRY SYSTEM; MODEL T8010 received FDA 510(k) clearance on 1995-10-06, under 510(k) number K951370.

Who is the listed applicant for ZYMED TELEMETRY SYSTEM; MODEL T8010?

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

What is the FDA product code for ZYMED TELEMETRY SYSTEM; MODEL T8010?

The FDA product code for ZYMED TELEMETRY SYSTEM; MODEL T8010 is DSI.

Related Clinical Trials

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Other records listing Zymed Medical Instrumentation 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.

K002004ZYBITK992197MODIFICATION TO ZYMED HOLTER 2000K990170HOLTER 2000K984089ZYMED TELEMETRY SYSTEM, MODEL EASI VIEWK955015ZYMED HOLTER SCANNER MODEL 2010K930894MULTITRAK-PLUS

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Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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