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FDA 510(k)

LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER

K-Number: K951096 · 1996-01-16

ApplicantInstromedix, Inc.
Decision Date1996-01-16
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1996-01-16 under 510(k) number K951096. 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 LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER?

LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER is a medical device that received FDA 510(k) clearance on 1996-01-16. The listed applicant is Instromedix, Inc.. The 510(k) number is K951096.

When did LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER receive FDA 510(k) clearance?

LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER received FDA 510(k) clearance on 1996-01-16, under 510(k) number K951096.

Who is the listed applicant for LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER?

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 LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER?

The FDA product code for LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER 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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