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FDA 510(k)

BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK

K-Number: K101130 · 2010-09-02

ApplicantRespironics, Inc.
Decision Date2010-09-02
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2010-09-02 under 510(k) number K101130. 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 2 WITH AF531 FULL FACE MASK?

BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK is a medical device that received FDA 510(k) clearance on 2010-09-02. The listed applicant is Respironics, Inc.. The 510(k) number is K101130.

When did BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK receive FDA 510(k) clearance?

BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK received FDA 510(k) clearance on 2010-09-02, under 510(k) number K101130.

Who is the listed applicant for BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK?

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 SYNCHRONY 2 WITH AF531 FULL FACE MASK?

The FDA product code for BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK 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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