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FDA 510(k)

VITEL III CM

K-Number: K880533 · 1988-05-13

ApplicantEquimed Corp.
Decision Date1988-05-13
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITEL III CM is the device name listed in this FDA 510(k) record. The listed applicant is Equimed Corp.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K880533. 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 VITEL III CM?

VITEL III CM is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Equimed Corp.. The 510(k) number is K880533.

When did VITEL III CM receive FDA 510(k) clearance?

VITEL III CM received FDA 510(k) clearance on 1988-05-13, under 510(k) number K880533.

Who is the listed applicant for VITEL III CM?

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

What is the FDA product code for VITEL III CM?

The FDA product code for VITEL III CM is DXH. This falls under the Hematology category.

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.

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Other records listing Equimed 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.

K872229VITEL III, ECG TRANSMITTER

Related Devices (Code: DXH)

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.

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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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