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FDA 510(k)

HYRDROMAX HMEF

K-Number: K130664 · 2013-06-21

ApplicantA-M Systems
Decision Date2013-06-21
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYRDROMAX HMEF is the device name listed in this FDA 510(k) record. The listed applicant is A-M Systems. It received FDA 510(k) clearance on 2013-06-21 under 510(k) number K130664. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYRDROMAX HMEF?

HYRDROMAX HMEF is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is A-M Systems. The 510(k) number is K130664.

When did HYRDROMAX HMEF receive FDA 510(k) clearance?

HYRDROMAX HMEF received FDA 510(k) clearance on 2013-06-21, under 510(k) number K130664.

Who is the listed applicant for HYRDROMAX HMEF?

The FDA 510(k) record lists A-M Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYRDROMAX HMEF?

The FDA product code for HYRDROMAX HMEF is CAH.

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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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