FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECA MF-20 MICROVASCULAR DOPPLER
K Number: K850071
·
Decision Apr 2, 1985
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
29
Review Days
83
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Basic Information
- Device Name
- TECA MF-20 MICROVASCULAR DOPPLER
- K Number
- K850071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Teca, Inc.
- Date Received
- January 9, 1985
- Decision Date
- April 2, 1985
- 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 Class 2
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Other Clearances by Teca, Inc.
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|---|---|---|---|
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| K884870 | TECA/MEDELEC 'CONCEPT' P420 | Feb 23, 1989 | Substantially Equivalent |
| K880593 | TECA/MEDELEC MISTRAL | Apr 6, 1988 | Substantially Equivalent |
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