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FDA 510(k)

CANARY BREATHING SYSTEM

K-Number: K131586 · 2013-12-10

ApplicantPalo Alto Health Sciences, Inc.
Decision Date2013-12-10
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CANARY BREATHING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Palo Alto Health Sciences, Inc.. It received FDA 510(k) clearance on 2013-12-10 under 510(k) number K131586. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANARY BREATHING SYSTEM?

CANARY BREATHING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-10. The listed applicant is Palo Alto Health Sciences, Inc.. The 510(k) number is K131586.

When did CANARY BREATHING SYSTEM receive FDA 510(k) clearance?

CANARY BREATHING SYSTEM received FDA 510(k) clearance on 2013-12-10, under 510(k) number K131586.

Who is the listed applicant for CANARY BREATHING SYSTEM?

The FDA 510(k) record lists Palo Alto Health Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANARY BREATHING SYSTEM?

The FDA product code for CANARY BREATHING SYSTEM is HCC.

Related Clinical Trials

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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Other records listing Palo Alto Health Sciences, 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.

K180173Freespira

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K122879EEGER4 MODEL 4.3Eeg Software, LLCK111687EMG SYSTEMMyotronics-Noromed, Inc.

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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