FDA 510(k)

VITALITH S 3000 SERIES

K-Number: K790666 · 1979-06-01

Decision Date1979-06-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VITALITH S 3000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Vitatron Medical BV. It received FDA 510(k) clearance on 1979-06-01 under 510(k) number K790666. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALITH S 3000 SERIES?

VITALITH S 3000 SERIES is a medical device that received FDA 510(k) clearance on 1979-06-01. The listed applicant is Vitatron Medical BV. The 510(k) number is K790666.

When did VITALITH S 3000 SERIES receive FDA 510(k) clearance?

VITALITH S 3000 SERIES received FDA 510(k) clearance on 1979-06-01, under 510(k) number K790666.

Who is the listed applicant for VITALITH S 3000 SERIES?

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

What is the FDA product code for VITALITH S 3000 SERIES?

The FDA product code for VITALITH S 3000 SERIES is DXY. This falls under the Clinical Chemistry category.

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Other records listing Vitatron Medical BV as applicant

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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.