FDA 510(k)

Talymed Suspension

Numéro K : K160695 · 2016-12-06

DemandeurMarine Polymer Technologies, Inc.

Date de décision2016-12-06

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

Talymed Suspension is the device name listed in this FDA 510(k) record. The listed applicant is Marine Polymer Technologies, Inc.. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K160695. 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.

Questions fréquentes

What is the Talymed Suspension?

Talymed Suspension is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Marine Polymer Technologies, Inc.. The 510(k) number is K160695.

When did Talymed Suspension receive FDA 510(k) clearance?

Talymed Suspension received FDA 510(k) clearance on 2016-12-06, under 510(k) number K160695.

Who is the listed applicant for Talymed Suspension?

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

What is the FDA product code for Talymed Suspension?

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

Essais cliniques associés

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Source officielle

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