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FDA 510(k)

OXIMETRY INTERFACE KIT

K-Number: K111378 · 2011-10-04

ApplicantPhilips Respironics, Inc.
Decision Date2011-10-04
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXIMETRY INTERFACE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Respironics, Inc.. It received FDA 510(k) clearance on 2011-10-04 under 510(k) number K111378. 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 OXIMETRY INTERFACE KIT?

OXIMETRY INTERFACE KIT is a medical device that received FDA 510(k) clearance on 2011-10-04. The listed applicant is Philips Respironics, Inc.. The 510(k) number is K111378.

When did OXIMETRY INTERFACE KIT receive FDA 510(k) clearance?

OXIMETRY INTERFACE KIT received FDA 510(k) clearance on 2011-10-04, under 510(k) number K111378.

Who is the listed applicant for OXIMETRY INTERFACE KIT?

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

What is the FDA product code for OXIMETRY INTERFACE KIT?

The FDA product code for OXIMETRY INTERFACE KIT is MNS. This falls under the Neurology category.

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Related Devices (Code: MNS)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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