FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VR LUNG ELECTROSONOGRAPH
K Number: K061495
·
Decision Jul 18, 2007
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
3
Review Days
413
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Basic Information
- Device Name
- VR LUNG ELECTROSONOGRAPH
- K Number
- K061495
- 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
- May 31, 2006
- Decision Date
- July 18, 2007
- 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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