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FDA 510(k)

VITALSENSE XHR

K-Number: K061870 · 2006-08-31

ApplicantRespironics, Inc.
Decision Date2006-08-31
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VITALSENSE XHR is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2006-08-31 under 510(k) number K061870. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALSENSE XHR?

VITALSENSE XHR is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Respironics, Inc.. The 510(k) number is K061870.

When did VITALSENSE XHR receive FDA 510(k) clearance?

VITALSENSE XHR received FDA 510(k) clearance on 2006-08-31, under 510(k) number K061870.

Who is the listed applicant for VITALSENSE XHR?

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 VITALSENSE XHR?

The FDA product code for VITALSENSE XHR is GWK.

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Related Devices (Code: GWK)

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

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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