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FDA 510(k)

HR VACUTRAC

K-Number: K881201 · 1988-05-16

ApplicantIcu Medical, Inc.
Decision Date1988-05-16
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HR VACUTRAC is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 1988-05-16 under 510(k) number K881201. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HR VACUTRAC?

HR VACUTRAC is a medical device that received FDA 510(k) clearance on 1988-05-16. The listed applicant is Icu Medical, Inc.. The 510(k) number is K881201.

When did HR VACUTRAC receive FDA 510(k) clearance?

HR VACUTRAC received FDA 510(k) clearance on 1988-05-16, under 510(k) number K881201.

Who is the listed applicant for HR VACUTRAC?

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

What is the FDA product code for HR VACUTRAC?

The FDA product code for HR VACUTRAC is JKA.

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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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