FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TEC 1410
K Number: K904397
·
Decision Nov 13, 1990
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
3
Review Days
49
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Basic Information
- Device Name
- TEC 1410
- K Number
- K904397
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Bay Shore Medical Equipment Corp.
- Date Received
- September 25, 1990
- Decision Date
- November 13, 1990
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
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