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FDA 510(k)

ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS

K-Number: K920364 · 1992-03-17

ApplicantBiosound, Inc.
Decision Date1992-03-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1992-03-17 under 510(k) number K920364. 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 ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS?

ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS is a medical device that received FDA 510(k) clearance on 1992-03-17. The listed applicant is Biosound, Inc.. The 510(k) number is K920364.

When did ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS received FDA 510(k) clearance on 1992-03-17, under 510(k) number K920364.

Who is the listed applicant for ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS?

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

What is the FDA product code for ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS?

The FDA product code for ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS is DPS.

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Other records listing Biosound, 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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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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