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FDA 510(k)

APNEALINK PLUS, MODEL: 22328

K-Number: K083575 · 2009-03-19

ApplicantResmed Germany, Inc.
Decision Date2009-03-19
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNEALINK PLUS, MODEL: 22328 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 2009-03-19 under 510(k) number K083575. 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 PLUS, MODEL: 22328?

APNEALINK PLUS, MODEL: 22328 is a medical device that received FDA 510(k) clearance on 2009-03-19. The listed applicant is Resmed Germany, Inc.. The 510(k) number is K083575.

When did APNEALINK PLUS, MODEL: 22328 receive FDA 510(k) clearance?

APNEALINK PLUS, MODEL: 22328 received FDA 510(k) clearance on 2009-03-19, under 510(k) number K083575.

Who is the listed applicant for APNEALINK PLUS, MODEL: 22328?

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 PLUS, MODEL: 22328?

The FDA product code for APNEALINK PLUS, MODEL: 22328 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 150K070263APNEALINKK061405APNEALINK, 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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