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FDA 510(k)

ZYBIT

K-Number: K002004 · 2000-09-21

ApplicantZymed Medical Instrumentation
Decision Date2000-09-21
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZYBIT 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 2000-09-21 under 510(k) number K002004. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYBIT?

ZYBIT is a medical device that received FDA 510(k) clearance on 2000-09-21. The listed applicant is Zymed Medical Instrumentation. The 510(k) number is K002004.

When did ZYBIT receive FDA 510(k) clearance?

ZYBIT received FDA 510(k) clearance on 2000-09-21, under 510(k) number K002004.

Who is the listed applicant for ZYBIT?

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 ZYBIT?

The FDA product code for ZYBIT is DXH. This falls under the Hematology category.

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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.

K992197MODIFICATION TO ZYMED HOLTER 2000K990170HOLTER 2000K984089ZYMED TELEMETRY SYSTEM, MODEL EASI VIEWK955015ZYMED HOLTER SCANNER MODEL 2010K951370ZYMED TELEMETRY SYSTEM; MODEL T8010K930894MULTITRAK-PLUS

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Related Devices (Code: DXH)

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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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