FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
K Number: K081661
·
Decision Jun 24, 2008
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
32
Review Days
11
Basic Information
- Device Name
- HD15 DIAGNOSTIC ULTRASOUND SYSTEM
- K Number
- K081661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHILIPS ULTRASOUND, INC.
- Date Received
- June 13, 2008
- Decision Date
- June 24, 2008
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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