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FDA 510(k)

STAT-CRIT HEMATOCRIT MEASURING INSTRU

K-Number: K802199 · 1981-02-04

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1981-02-04
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAT-CRIT HEMATOCRIT MEASURING INSTRU is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1981-02-04 under 510(k) number K802199. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT-CRIT HEMATOCRIT MEASURING INSTRU?

STAT-CRIT HEMATOCRIT MEASURING INSTRU is a medical device that received FDA 510(k) clearance on 1981-02-04. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K802199.

When did STAT-CRIT HEMATOCRIT MEASURING INSTRU receive FDA 510(k) clearance?

STAT-CRIT HEMATOCRIT MEASURING INSTRU received FDA 510(k) clearance on 1981-02-04, under 510(k) number K802199.

Who is the listed applicant for STAT-CRIT HEMATOCRIT MEASURING INSTRU?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAT-CRIT HEMATOCRIT MEASURING INSTRU?

The FDA product code for STAT-CRIT HEMATOCRIT MEASURING INSTRU is GKF.

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Related Devices (Code: GKF)

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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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