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FDA 510(k)

PACER MONITOR, PULSE WIDTH

K-Number: K772178 · 1977-12-08

ApplicantSurvival Technology, Inc.
Decision Date1977-12-08
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACER MONITOR, PULSE WIDTH is the device name listed in this FDA 510(k) record. The listed applicant is Survival Technology, Inc.. It received FDA 510(k) clearance on 1977-12-08 under 510(k) number K772178. 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 PACER MONITOR, PULSE WIDTH?

PACER MONITOR, PULSE WIDTH is a medical device that received FDA 510(k) clearance on 1977-12-08. The listed applicant is Survival Technology, Inc.. The 510(k) number is K772178.

When did PACER MONITOR, PULSE WIDTH receive FDA 510(k) clearance?

PACER MONITOR, PULSE WIDTH received FDA 510(k) clearance on 1977-12-08, under 510(k) number K772178.

Who is the listed applicant for PACER MONITOR, PULSE WIDTH?

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

What is the FDA product code for PACER MONITOR, PULSE WIDTH?

The FDA product code for PACER MONITOR, PULSE WIDTH 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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