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FDA 510(k)

VITA-STAT MODEL 8000-C

K-Number: K811146 · 1981-06-30

ApplicantVita-Stat
Decision Date1981-06-30
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITA-STAT MODEL 8000-C is the device name listed in this FDA 510(k) record. The listed applicant is Vita-Stat. It received FDA 510(k) clearance on 1981-06-30 under 510(k) number K811146. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITA-STAT MODEL 8000-C?

VITA-STAT MODEL 8000-C is a medical device that received FDA 510(k) clearance on 1981-06-30. The listed applicant is Vita-Stat. The 510(k) number is K811146.

When did VITA-STAT MODEL 8000-C receive FDA 510(k) clearance?

VITA-STAT MODEL 8000-C received FDA 510(k) clearance on 1981-06-30, under 510(k) number K811146.

Who is the listed applicant for VITA-STAT MODEL 8000-C?

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

What is the FDA product code for VITA-STAT MODEL 8000-C?

The FDA product code for VITA-STAT MODEL 8000-C is DSK.

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 Vita-Stat 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.

K895586VVR/Q CALORIMETERK811147VITA-STAT MODEL 9000-A

Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, Inc.

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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