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FDA 510(k)

PCI MODEL 2041-A TELEMETRY MONITOR

K-Number: K894340 · 1989-10-02

ApplicantAccucore, Inc.
Decision Date1989-10-02
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PCI MODEL 2041-A TELEMETRY 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 1989-10-02 under 510(k) number K894340. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCI MODEL 2041-A TELEMETRY MONITOR?

PCI MODEL 2041-A TELEMETRY MONITOR is a medical device that received FDA 510(k) clearance on 1989-10-02. The listed applicant is Accucore, Inc.. The 510(k) number is K894340.

When did PCI MODEL 2041-A TELEMETRY MONITOR receive FDA 510(k) clearance?

PCI MODEL 2041-A TELEMETRY MONITOR received FDA 510(k) clearance on 1989-10-02, under 510(k) number K894340.

Who is the listed applicant for PCI MODEL 2041-A TELEMETRY 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 PCI MODEL 2041-A TELEMETRY MONITOR?

The FDA product code for PCI MODEL 2041-A TELEMETRY MONITOR is DXH. This falls under the Hematology category.

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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: DXH)

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.

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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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