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FDA 510(k)

BIPAP SYNCHRONY WITH AVAPS

K-Number: K070328 · 2007-05-08

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2007-05-08
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIPAP SYNCHRONY WITH AVAPS is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. It received FDA 510(k) clearance on 2007-05-08 under 510(k) number K070328. 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 SYNCHRONY WITH AVAPS?

BIPAP SYNCHRONY WITH AVAPS is a medical device that received FDA 510(k) clearance on 2007-05-08. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K070328.

When did BIPAP SYNCHRONY WITH AVAPS receive FDA 510(k) clearance?

BIPAP SYNCHRONY WITH AVAPS received FDA 510(k) clearance on 2007-05-08, under 510(k) number K070328.

Who is the listed applicant for BIPAP SYNCHRONY WITH AVAPS?

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

What is the FDA product code for BIPAP SYNCHRONY WITH AVAPS?

The FDA product code for BIPAP SYNCHRONY WITH AVAPS 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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