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FDA 510(k)

AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)

K-Number: K003330 · 2001-01-04

ApplicantAktina Medical Physics Corp.
Decision Date2001-01-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) is the device name listed in this FDA 510(k) record. The listed applicant is Aktina Medical Physics Corp.. It received FDA 510(k) clearance on 2001-01-04 under 510(k) number K003330. 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 AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)?

AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Aktina Medical Physics Corp.. The 510(k) number is K003330.

When did AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) receive FDA 510(k) clearance?

AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) received FDA 510(k) clearance on 2001-01-04, under 510(k) number K003330.

Who is the listed applicant for AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)?

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

What is the FDA product code for AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)?

The FDA product code for AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) is IYE.

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Other records listing Aktina Medical Physics Corp. as applicant

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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