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FDA 510(k)

VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH

K-Number: K803309 · 1981-01-16

Decision Date1981-01-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803309. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH?

VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K803309.

When did VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803309.

Who is the listed applicant for VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH?

The FDA 510(k) record lists Advanced Technology Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH?

The FDA product code for VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH is DPS.

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.

Other records listing Advanced Technology Laboratories, Inc. 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.

View all 61 devices →

Related Devices (Code: DPS)

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.

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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