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FDA 510(k)

NIVATOPIC PLUS

K-Number: K132329 · 2013-12-20

ApplicantNivagen Pharmaceuticals, Inc.
Decision Date2013-12-20
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

NIVATOPIC PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Nivagen Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132329. 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 NIVATOPIC PLUS?

NIVATOPIC PLUS is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Nivagen Pharmaceuticals, Inc.. The 510(k) number is K132329.

When did NIVATOPIC PLUS receive FDA 510(k) clearance?

NIVATOPIC PLUS received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132329.

Who is the listed applicant for NIVATOPIC PLUS?

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

What is the FDA product code for NIVATOPIC PLUS?

The FDA product code for NIVATOPIC PLUS 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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