FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE
K Number: K911320
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
3
Review Days
267
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Basic Information
- Device Name
- EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE
- K Number
- K911320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Biometrics, Inc.
- Date Received
- March 26, 1991
- Decision Date
- December 18, 1991
- Product Code
- JOP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
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