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FDA 510(k)

ACTIVE BREATHING COORDINATOR

K-Number: K131313 · 2013-08-07

ApplicantAktina Medical Corp.
Decision Date2013-08-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACTIVE BREATHING COORDINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Aktina Medical Corp.. It received FDA 510(k) clearance on 2013-08-07 under 510(k) number K131313. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVE BREATHING COORDINATOR?

ACTIVE BREATHING COORDINATOR is a medical device that received FDA 510(k) clearance on 2013-08-07. The listed applicant is Aktina Medical Corp.. The 510(k) number is K131313.

When did ACTIVE BREATHING COORDINATOR receive FDA 510(k) clearance?

ACTIVE BREATHING COORDINATOR received FDA 510(k) clearance on 2013-08-07, under 510(k) number K131313.

Who is the listed applicant for ACTIVE BREATHING COORDINATOR?

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

What is the FDA product code for ACTIVE BREATHING COORDINATOR?

The FDA product code for ACTIVE BREATHING COORDINATOR is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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