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FDA 510(k)

CARDIOSTAT 3 RECORDER

K-Number: K851044 · 1985-06-26

ApplicantSiemens Elema AB
Decision Date1985-06-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSTAT 3 RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1985-06-26 under 510(k) number K851044. 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 CARDIOSTAT 3 RECORDER?

CARDIOSTAT 3 RECORDER is a medical device that received FDA 510(k) clearance on 1985-06-26. The listed applicant is Siemens Elema AB. The 510(k) number is K851044.

When did CARDIOSTAT 3 RECORDER receive FDA 510(k) clearance?

CARDIOSTAT 3 RECORDER received FDA 510(k) clearance on 1985-06-26, under 510(k) number K851044.

Who is the listed applicant for CARDIOSTAT 3 RECORDER?

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

What is the FDA product code for CARDIOSTAT 3 RECORDER?

The FDA product code for CARDIOSTAT 3 RECORDER is DPS.

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Other records listing Siemens Elema AB as applicant

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Related Devices (Code: DPS)

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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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