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FDA 510(k)

NEOSALUS

K-Number: K070309 · 2008-09-12

ApplicantQuinnova Pharmaceuticals
Decision Date2008-09-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

NEOSALUS is the device name listed in this FDA 510(k) record. The listed applicant is Quinnova Pharmaceuticals. It received FDA 510(k) clearance on 2008-09-12 under 510(k) number K070309. 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 NEOSALUS?

NEOSALUS is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Quinnova Pharmaceuticals. The 510(k) number is K070309.

When did NEOSALUS receive FDA 510(k) clearance?

NEOSALUS received FDA 510(k) clearance on 2008-09-12, under 510(k) number K070309.

Who is the listed applicant for NEOSALUS?

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

What is the FDA product code for NEOSALUS?

The FDA product code for NEOSALUS is FRO. This falls under the Anesthesiology category.

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Other records listing Quinnova Pharmaceuticals 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.

K091719NEOSALUS LOTIONK090585NEOSALUS CREAM

Related Devices (Code: FRO)

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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