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FDA 510(k)

BIPAP AUTOSV

K-Number: K063540 · 2007-02-22

ApplicantRespironics, Inc.
Decision Date2007-02-22
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIPAP AUTOSV is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2007-02-22 under 510(k) number K063540. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPAP AUTOSV?

BIPAP AUTOSV is a medical device that received FDA 510(k) clearance on 2007-02-22. The listed applicant is Respironics, Inc.. The 510(k) number is K063540.

When did BIPAP AUTOSV receive FDA 510(k) clearance?

BIPAP AUTOSV received FDA 510(k) clearance on 2007-02-22, under 510(k) number K063540.

Who is the listed applicant for BIPAP AUTOSV?

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

What is the FDA product code for BIPAP AUTOSV?

The FDA product code for BIPAP AUTOSV is MNS. This falls under the Neurology category.

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Related Devices (Code: MNS)

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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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