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FDA 510(k)

INSTANT REPLAY

K-Number: K840587 · 1984-10-26

ApplicantInstromedix, Inc.
Decision Date1984-10-26
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INSTANT REPLAY is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1984-10-26 under 510(k) number K840587. 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 INSTANT REPLAY?

INSTANT REPLAY is a medical device that received FDA 510(k) clearance on 1984-10-26. The listed applicant is Instromedix, Inc.. The 510(k) number is K840587.

When did INSTANT REPLAY receive FDA 510(k) clearance?

INSTANT REPLAY received FDA 510(k) clearance on 1984-10-26, under 510(k) number K840587.

Who is the listed applicant for INSTANT REPLAY?

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

What is the FDA product code for INSTANT REPLAY?

The FDA product code for INSTANT REPLAY is DXH. This falls under the Hematology category.

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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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