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FDA 510(k)

PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS

K-Number: K880283 · 1988-03-09

ApplicantPaceart, Inc.
Decision Date1988-03-09
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1988-03-09 under 510(k) number K880283. 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 PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS?

PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS is a medical device that received FDA 510(k) clearance on 1988-03-09. The listed applicant is Paceart, Inc.. The 510(k) number is K880283.

When did PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS receive FDA 510(k) clearance?

PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS received FDA 510(k) clearance on 1988-03-09, under 510(k) number K880283.

Who is the listed applicant for PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS?

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

What is the FDA product code for PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS?

The FDA product code for PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS is DXH. This falls under the Hematology category.

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Other records listing Paceart, Inc. as applicant

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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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