FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITALSENSE XHR
K Number: K061870
·
Decision Aug 31, 2006
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
22
Applicant Total
172
Review Days
59
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Basic Information
- Device Name
- VITALSENSE XHR
- K Number
- K061870
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1845
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- July 3, 2006
- Decision Date
- August 31, 2006
- Product Code
- GWK
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWK | Conditioner, Signal, Physiological | FDA class 2 | Neurology |
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