Vitalsense XHR
FDA 510(k) K061870 · Respironics, Inc.
510(k) numberK061870
Submission
- Device name
- Vitalsense XHR
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- July 3, 2006
- Decision date
- August 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vitalsense XHR cleared by the FDA?
Vitalsense XHR (K061870) received a 510(k) decision of Substantially Equivalent on August 31, 2006, 59 days after the submission was received.
What is the product code of K061870?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.