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FDA 510(k)

AIR/FLUID EXCHANGE SYSTEM

K-Number: K855215 · 1986-02-27

ApplicantMira, Inc.
Decision Date1986-02-27
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIR/FLUID EXCHANGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mira, Inc.. It received FDA 510(k) clearance on 1986-02-27 under 510(k) number K855215. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR/FLUID EXCHANGE SYSTEM?

AIR/FLUID EXCHANGE SYSTEM is a medical device that received FDA 510(k) clearance on 1986-02-27. The listed applicant is Mira, Inc.. The 510(k) number is K855215.

When did AIR/FLUID EXCHANGE SYSTEM receive FDA 510(k) clearance?

AIR/FLUID EXCHANGE SYSTEM received FDA 510(k) clearance on 1986-02-27, under 510(k) number K855215.

Who is the listed applicant for AIR/FLUID EXCHANGE SYSTEM?

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

What is the FDA product code for AIR/FLUID EXCHANGE SYSTEM?

The FDA product code for AIR/FLUID EXCHANGE SYSTEM is FRN.

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Other records listing Mira, Inc. as applicant

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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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