FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
K Number: K910020
·
Decision Apr 8, 1991
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
7
Review Days
95
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Basic Information
- Device Name
- CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
- K Number
- K910020
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Capintec Instruments, Inc.
- Date Received
- January 3, 1991
- Decision Date
- April 8, 1991
- 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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Other Clearances by Capintec Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943072 | BETA C COUNTER | Sep 29, 1994 | Substantially Equivalent |
| K935539 | CAPINTEC CRC 35R | Feb 18, 1994 | Substantially Equivalent |
| K930962 | CAPTUS 2000 WEL COUNTER | May 18, 1993 | Substantially Equivalent |
| K924586 | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | Dec 3, 1992 | Substantially Equivalent |
| K921428 | CAPTUS 500 | May 28, 1992 | Substantially Equivalent |
| K905796 | DOSE CALIBRATOR | Mar 18, 1991 | Substantially Equivalent |