FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECA TC2-64 TRANSCRANIAL DOPPLER
K Number: K850137
·
Decision Aug 14, 1985
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
29
Review Days
212
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Basic Information
- Device Name
- TECA TC2-64 TRANSCRANIAL DOPPLER
- K Number
- K850137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Teca, Inc.
- Date Received
- January 14, 1985
- Decision Date
- August 14, 1985
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K880593 | TECA/MEDELEC MISTRAL | Apr 6, 1988 | Substantially Equivalent |
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