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FDA 510(k)

APNEALINK, MODEL 22302

K-Number: K061405 · 2006-07-25

ApplicantResmed Germany, Inc.
Decision Date2006-07-25
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNEALINK, MODEL 22302 is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Germany, Inc.. It received FDA 510(k) clearance on 2006-07-25 under 510(k) number K061405. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APNEALINK, MODEL 22302?

APNEALINK, MODEL 22302 is a medical device that received FDA 510(k) clearance on 2006-07-25. The listed applicant is Resmed Germany, Inc.. The 510(k) number is K061405.

When did APNEALINK, MODEL 22302 receive FDA 510(k) clearance?

APNEALINK, MODEL 22302 received FDA 510(k) clearance on 2006-07-25, under 510(k) number K061405.

Who is the listed applicant for APNEALINK, MODEL 22302?

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

What is the FDA product code for APNEALINK, MODEL 22302?

The FDA product code for APNEALINK, MODEL 22302 is MNR.

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Other records listing Resmed Germany, 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.

K131932APNEALINK PROK122715STELLAR 150K113640STELLAR 150K103167STELLAR 150K083575APNEALINK PLUS, MODEL: 22328K070263APNEALINK

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Related Devices (Code: MNR)

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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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