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FDA 510(k)

IMD PSD 410 PACEMAKER TRANSMITTER

K-Number: K943995 · 1995-03-07

ApplicantIntegrated Medical Devices, Inc.
Decision Date1995-03-07
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMD PSD 410 PACEMAKER TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Medical Devices, Inc.. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K943995. 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 IMD PSD 410 PACEMAKER TRANSMITTER?

IMD PSD 410 PACEMAKER TRANSMITTER is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Integrated Medical Devices, Inc.. The 510(k) number is K943995.

When did IMD PSD 410 PACEMAKER TRANSMITTER receive FDA 510(k) clearance?

IMD PSD 410 PACEMAKER TRANSMITTER received FDA 510(k) clearance on 1995-03-07, under 510(k) number K943995.

Who is the listed applicant for IMD PSD 410 PACEMAKER TRANSMITTER?

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

What is the FDA product code for IMD PSD 410 PACEMAKER TRANSMITTER?

The FDA product code for IMD PSD 410 PACEMAKER TRANSMITTER is DXH. This falls under the Hematology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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