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FDA 510(k)

BREATH SHAKE

K-Number: K121587 · 2013-11-22

ApplicantCheen Houng Ent. Co. , Ltd.
Decision Date2013-11-22
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATH SHAKE is the device name listed in this FDA 510(k) record. The listed applicant is Cheen Houng Ent. Co. , Ltd.. It received FDA 510(k) clearance on 2013-11-22 under 510(k) number K121587. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATH SHAKE?

BREATH SHAKE is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is Cheen Houng Ent. Co. , Ltd.. The 510(k) number is K121587.

When did BREATH SHAKE receive FDA 510(k) clearance?

BREATH SHAKE received FDA 510(k) clearance on 2013-11-22, under 510(k) number K121587.

Who is the listed applicant for BREATH SHAKE?

The FDA 510(k) record lists Cheen Houng Ent. Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREATH SHAKE?

The FDA product code for BREATH SHAKE is BYI.

Related Clinical Trials

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Other records listing Cheen Houng Ent. Co. , 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.

K021390PMX COMPACT RESUCITATORK003927Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02K010191Y2000 POCKET RESCUEK9814150-20 CM H20 PEEP VALVEK970688POCKET RESCUE

Related Devices (Code: BYI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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