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FDA 510(k)

BIOPHYSICAL MONITORING SYSTEM

K-Number: K780425 · 1978-04-28

ApplicantGould, Inc.
Decision Date1978-04-28
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOPHYSICAL MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1978-04-28 under 510(k) number K780425. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPHYSICAL MONITORING SYSTEM?

BIOPHYSICAL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1978-04-28. The listed applicant is Gould, Inc.. The 510(k) number is K780425.

When did BIOPHYSICAL MONITORING SYSTEM receive FDA 510(k) clearance?

BIOPHYSICAL MONITORING SYSTEM received FDA 510(k) clearance on 1978-04-28, under 510(k) number K780425.

Who is the listed applicant for BIOPHYSICAL MONITORING SYSTEM?

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

What is the FDA product code for BIOPHYSICAL MONITORING SYSTEM?

The FDA product code for BIOPHYSICAL MONITORING SYSTEM is DXJ.

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Other records listing Gould, 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.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

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Related Devices (Code: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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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