FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VRLXP, MODEL XP
K Number: K091732
·
Decision Mar 4, 2010
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
3
Review Days
266
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Basic Information
- Device Name
- VRLXP, MODEL XP
- K Number
- K091732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deep Breeze , Ltd.
- Date Received
- June 11, 2009
- Decision Date
- March 4, 2010
- Product Code
- OCR
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| OCR | Lung Sound Monitor | FDA class 2 | Cardiovascular |
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