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FDA 510(k)

ABSOCLEAR

K-Number: K130553 · 2013-07-03

ApplicantPharmaplast S.A.E.
Decision Date2013-07-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ABSOCLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaplast S.A.E.. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K130553. 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 ABSOCLEAR?

ABSOCLEAR is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Pharmaplast S.A.E.. The 510(k) number is K130553.

When did ABSOCLEAR receive FDA 510(k) clearance?

ABSOCLEAR received FDA 510(k) clearance on 2013-07-03, under 510(k) number K130553.

Who is the listed applicant for ABSOCLEAR?

The FDA 510(k) record lists Pharmaplast S.A.E. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSOCLEAR?

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

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Related Devices (Code: FRO)

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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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