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FDA 510(k)

ZYMED HOLTER SCANNER MODEL 2010

K-Number: K955015 · 1996-03-18

ApplicantZymed Medical Instrumentation
Decision Date1996-03-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZYMED HOLTER SCANNER MODEL 2010 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 1996-03-18 under 510(k) number K955015. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYMED HOLTER SCANNER MODEL 2010?

ZYMED HOLTER SCANNER MODEL 2010 is a medical device that received FDA 510(k) clearance on 1996-03-18. The listed applicant is Zymed Medical Instrumentation. The 510(k) number is K955015.

When did ZYMED HOLTER SCANNER MODEL 2010 receive FDA 510(k) clearance?

ZYMED HOLTER SCANNER MODEL 2010 received FDA 510(k) clearance on 1996-03-18, under 510(k) number K955015.

Who is the listed applicant for ZYMED HOLTER SCANNER MODEL 2010?

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 HOLTER SCANNER MODEL 2010?

The FDA product code for ZYMED HOLTER SCANNER MODEL 2010 is DQK.

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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 VIEWK951370ZYMED TELEMETRY SYSTEM; MODEL T8010K930894MULTITRAK-PLUS

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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