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FDA 510(k)

AG GUFFILL

K-Number: K122721 · 2013-05-03

ApplicantHospitech Respiration , Ltd.
Decision Date2013-05-03
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AG GUFFILL is the device name listed in this FDA 510(k) record. The listed applicant is Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2013-05-03 under 510(k) number K122721. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AG GUFFILL?

AG GUFFILL is a medical device that received FDA 510(k) clearance on 2013-05-03. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K122721.

When did AG GUFFILL receive FDA 510(k) clearance?

AG GUFFILL received FDA 510(k) clearance on 2013-05-03, under 510(k) number K122721.

Who is the listed applicant for AG GUFFILL?

The FDA 510(k) record lists Hospitech Respiration , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AG GUFFILL?

The FDA product code for AG GUFFILL is BSK.

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Other records listing Hospitech Respiration , Ltd. 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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Related Devices (Code: BSK)

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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