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FDA 510(k)

PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA

K-Number: K901032 · 1990-04-04

ApplicantAccucore, Inc.
Decision Date1990-04-04
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA is the device name listed in this FDA 510(k) record. The listed applicant is Accucore, Inc.. It received FDA 510(k) clearance on 1990-04-04 under 510(k) number K901032. 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 PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA?

PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA is a medical device that received FDA 510(k) clearance on 1990-04-04. The listed applicant is Accucore, Inc.. The 510(k) number is K901032.

When did PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA receive FDA 510(k) clearance?

PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA received FDA 510(k) clearance on 1990-04-04, under 510(k) number K901032.

Who is the listed applicant for PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA?

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 PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA?

The FDA product code for PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA is DPS.

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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 MONITORK913576DATASCOPE MODEL VISA CENTRAL MONITORK913400MODEL SCR-1000K901031PCI MODEL 2041-PC TELEMETRY MONITORK896775PCI MODEL 2041-B TELEMETRY MONITOR

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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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