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FDA 510(k)

TALYMED

K-Number: K102002 · 2010-07-28

ApplicantMarine Polymer Technologies
Decision Date2010-07-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TALYMED is the device name listed in this FDA 510(k) record. The listed applicant is Marine Polymer Technologies. It received FDA 510(k) clearance on 2010-07-28 under 510(k) number K102002. 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 TALYMED?

TALYMED is a medical device that received FDA 510(k) clearance on 2010-07-28. The listed applicant is Marine Polymer Technologies. The 510(k) number is K102002.

When did TALYMED receive FDA 510(k) clearance?

TALYMED received FDA 510(k) clearance on 2010-07-28, under 510(k) number K102002.

Who is the listed applicant for TALYMED?

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

What is the FDA product code for TALYMED?

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

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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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