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FDA 510(k)

DATASCOPE MODEL VISA CENTRAL MONITOR

K-Number: K913576 · 1992-01-28

ApplicantAccucore, Inc.
Decision Date1992-01-28
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATASCOPE MODEL VISA CENTRAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Accucore, Inc.. It received FDA 510(k) clearance on 1992-01-28 under 510(k) number K913576. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATASCOPE MODEL VISA CENTRAL MONITOR?

DATASCOPE MODEL VISA CENTRAL MONITOR is a medical device that received FDA 510(k) clearance on 1992-01-28. The listed applicant is Accucore, Inc.. The 510(k) number is K913576.

When did DATASCOPE MODEL VISA CENTRAL MONITOR receive FDA 510(k) clearance?

DATASCOPE MODEL VISA CENTRAL MONITOR received FDA 510(k) clearance on 1992-01-28, under 510(k) number K913576.

Who is the listed applicant for DATASCOPE MODEL VISA CENTRAL MONITOR?

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

What is the FDA product code for DATASCOPE MODEL VISA CENTRAL MONITOR?

The FDA product code for DATASCOPE MODEL VISA CENTRAL MONITOR is DSI.

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Other records listing Accucore, 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.

K942147PACIFIC COMMUNICATIONS MODEL 1100K925411MODEL 2041-PC/ST CARDIAC TELEMETRY MONITORK913400MODEL SCR-1000K896775PCI MODEL 2041-B TELEMETRY MONITORK901031PCI MODEL 2041-PC TELEMETRY MONITORK901032PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA

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Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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