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FDA 510(k)

VIVALITH 5, - MDL-201A & TDL-201A

K-Number: K801763 · 1980-08-27

ApplicantPacesetter Systems
Decision Date1980-08-27
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIVALITH 5, - MDL-201A & TDL-201A is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801763. 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 VIVALITH 5, - MDL-201A & TDL-201A?

VIVALITH 5, - MDL-201A & TDL-201A is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Pacesetter Systems. The 510(k) number is K801763.

When did VIVALITH 5, - MDL-201A & TDL-201A receive FDA 510(k) clearance?

VIVALITH 5, - MDL-201A & TDL-201A received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801763.

Who is the listed applicant for VIVALITH 5, - MDL-201A & TDL-201A?

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

What is the FDA product code for VIVALITH 5, - MDL-201A & TDL-201A?

The FDA product code for VIVALITH 5, - MDL-201A & TDL-201A is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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

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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