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FDA 510(k)

CARDIOSTAT 1 ECG RECORDER

K-Number: K844392 · 1985-04-11

ApplicantSiemens Elema AB
Decision Date1985-04-11
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSTAT 1 ECG 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 1985-04-11 under 510(k) number K844392. 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 1 ECG RECORDER?

CARDIOSTAT 1 ECG RECORDER is a medical device that received FDA 510(k) clearance on 1985-04-11. The listed applicant is Siemens Elema AB. The 510(k) number is K844392.

When did CARDIOSTAT 1 ECG RECORDER receive FDA 510(k) clearance?

CARDIOSTAT 1 ECG RECORDER received FDA 510(k) clearance on 1985-04-11, under 510(k) number K844392.

Who is the listed applicant for CARDIOSTAT 1 ECG 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 1 ECG RECORDER?

The FDA product code for CARDIOSTAT 1 ECG RECORDER is DPS.

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300A

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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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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