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FDA 510(k)

ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085

K-Number: K122996 · 2013-04-10

ApplicantXhale
Decision Date2013-04-10
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 is the device name listed in this FDA 510(k) record. The listed applicant is Xhale. It received FDA 510(k) clearance on 2013-04-10 under 510(k) number K122996. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085?

ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 is a medical device that received FDA 510(k) clearance on 2013-04-10. The listed applicant is Xhale. The 510(k) number is K122996.

When did ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 receive FDA 510(k) clearance?

ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 received FDA 510(k) clearance on 2013-04-10, under 510(k) number K122996.

Who is the listed applicant for ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085?

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

What is the FDA product code for ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085?

The FDA product code for ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 is DQA.

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Related Devices (Code: DQA)

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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