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FDA 510(k)

EMULSION SB

K-Number: K110732 · 2011-06-03

ApplicantPrugen IP Holdings, Inc.
Decision Date2011-06-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

EMULSION SB is the device name listed in this FDA 510(k) record. The listed applicant is Prugen IP Holdings, Inc.. It received FDA 510(k) clearance on 2011-06-03 under 510(k) number K110732. 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 EMULSION SB?

EMULSION SB is a medical device that received FDA 510(k) clearance on 2011-06-03. The listed applicant is Prugen IP Holdings, Inc.. The 510(k) number is K110732.

When did EMULSION SB receive FDA 510(k) clearance?

EMULSION SB received FDA 510(k) clearance on 2011-06-03, under 510(k) number K110732.

Who is the listed applicant for EMULSION SB?

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

What is the FDA product code for EMULSION SB?

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

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Other records listing Prugen IP Holdings, Inc. 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.

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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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