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FDA 510(k)

ICU STOPCOK WITH EXTENSION TUBING

K-Number: K953573 · 1995-10-07

ApplicantIcu Medical, Inc.
Decision Date1995-10-07
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ICU STOPCOK WITH EXTENSION TUBING 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 1995-10-07 under 510(k) number K953573. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICU STOPCOK WITH EXTENSION TUBING?

ICU STOPCOK WITH EXTENSION TUBING is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Icu Medical, Inc.. The 510(k) number is K953573.

When did ICU STOPCOK WITH EXTENSION TUBING receive FDA 510(k) clearance?

ICU STOPCOK WITH EXTENSION TUBING received FDA 510(k) clearance on 1995-10-07, under 510(k) number K953573.

Who is the listed applicant for ICU STOPCOK WITH EXTENSION TUBING?

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 ICU STOPCOK WITH EXTENSION TUBING?

The FDA product code for ICU STOPCOK WITH EXTENSION TUBING is FMG.

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Related Devices (Code: FMG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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