FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRC-15BT
K Number: K020150
·
Decision Aug 2, 2002
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
14
Review Days
198
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Basic Information
- Device Name
- CRC-15BT
- K Number
- K020150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1360
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Capintec, Inc.
- Date Received
- January 16, 2002
- Decision Date
- August 2, 2002
- Product Code
- KPT
- 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 |
|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | FDA class 2 | Radiology |
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Other Clearances by Capintec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1 | Sep 12, 2019 | Substantially Equivalent |
| K162394 | CRC-77tHR | Mar 8, 2017 | Substantially Equivalent |
| K141413 | CRC PC WITH SMART CHAMBER | Jun 27, 2014 | Substantially Equivalent |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | Aug 9, 2010 | Substantially Equivalent |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Jun 28, 2007 | Substantially Equivalent |
| K052595 | CRC 15ULTRA | Nov 8, 2005 | Substantially Equivalent |
| K030175 | 2 BASIC | Apr 17, 2003 | Substantially Equivalent |
| K982448 | CARDIOLIGHT | Jun 11, 1999 | Substantially Equivalent |
| K980402 | CAPINTEC MODEL 292 ELECTROMETER | Apr 24, 1998 | Substantially Equivalent |
| K946387 | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | Mar 30, 1995 | Substantially Equivalent |