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FDA 510(k)

APNEALINK

K-Number: K070263 · 2007-06-15

ApplicantResmed Germany, Inc.
Decision Date2007-06-15
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNEALINK 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 2007-06-15 under 510(k) number K070263. 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?

APNEALINK is a medical device that received FDA 510(k) clearance on 2007-06-15. The listed applicant is Resmed Germany, Inc.. The 510(k) number is K070263.

When did APNEALINK receive FDA 510(k) clearance?

APNEALINK received FDA 510(k) clearance on 2007-06-15, under 510(k) number K070263.

Who is the listed applicant for APNEALINK?

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?

The FDA product code for APNEALINK 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: 22328K061405APNEALINK, MODEL 22302

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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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