FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS
K Number: K914862
·
Decision Dec 3, 1992
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
19
Review Days
401
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Basic Information
- Device Name
- CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS
- K Number
- K914862
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medasonics, Inc.
- Date Received
- October 29, 1991
- Decision Date
- December 3, 1992
- Product Code
- IYN
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Medasonics, Inc.
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|---|---|---|---|
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| K961116 | FIRST BEAT/CARDIO BEAT/CALC | Aug 8, 1996 | Substantially Equivalent |
| K911453 | OBTRASOUND STETHOSCOPE FETAL CALC | Jun 20, 1991 | Substantially Equivalent |
| K882018 | MEDACORD PVL, PERSONAL VASCULAR LABORATORY | Sep 21, 1988 | Substantially Equivalent |
| K872292 | TRANSPECT TRANSCRANIAL DOPPLER | Aug 14, 1987 | Substantially Equivalent |
| K854734 | MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE | Feb 10, 1986 | Substantially Equivalent |
| K833588 | VASCULAR LABORATORY TREADMILL VT1 | Nov 14, 1983 | Substantially Equivalent |
| K837481 | BF24 DOPPLER MODEL P872 AND P874 | Jun 24, 1983 | Substantially Equivalent |
| K831393 | VASCULAB BLOOD PRESSURE CUFF | Jun 16, 1983 | Substantially Equivalent |