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FDA 510(k)

BIPAP HARMONY VENTILATORY SUPPORT SYSTEM

K-Number: K031656 · 2003-07-30

ApplicantRespironics, Inc.
Decision Date2003-07-30
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIPAP HARMONY VENTILATORY SUPPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2003-07-30 under 510(k) number K031656. 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 HARMONY VENTILATORY SUPPORT SYSTEM?

BIPAP HARMONY VENTILATORY SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-07-30. The listed applicant is Respironics, Inc.. The 510(k) number is K031656.

When did BIPAP HARMONY VENTILATORY SUPPORT SYSTEM receive FDA 510(k) clearance?

BIPAP HARMONY VENTILATORY SUPPORT SYSTEM received FDA 510(k) clearance on 2003-07-30, under 510(k) number K031656.

Who is the listed applicant for BIPAP HARMONY VENTILATORY SUPPORT SYSTEM?

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 HARMONY VENTILATORY SUPPORT SYSTEM?

The FDA product code for BIPAP HARMONY VENTILATORY SUPPORT SYSTEM is MNS. This falls under the Neurology category.

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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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