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FDA 510(k)

HEALADEX-P

K-Number: K063517 · 2007-02-16

ApplicantHealagenics, Inc.
Decision Date2007-02-16
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HEALADEX-P is the device name listed in this FDA 510(k) record. The listed applicant is Healagenics, Inc.. It received FDA 510(k) clearance on 2007-02-16 under 510(k) number K063517. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALADEX-P?

HEALADEX-P is a medical device that received FDA 510(k) clearance on 2007-02-16. The listed applicant is Healagenics, Inc.. The 510(k) number is K063517.

When did HEALADEX-P receive FDA 510(k) clearance?

HEALADEX-P received FDA 510(k) clearance on 2007-02-16, under 510(k) number K063517.

Who is the listed applicant for HEALADEX-P?

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

What is the FDA product code for HEALADEX-P?

The FDA product code for HEALADEX-P is FRO. This falls under the Anesthesiology category.

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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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