FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROBE, UPTAKE, NUCLEAR
K Number: K864624
·
Decision Aug 10, 1987
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
11
Review Days
258
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Basic Information
- Device Name
- PROBE, UPTAKE, NUCLEAR
- K Number
- K864624
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Carolina Medical Electronics
- Date Received
- November 25, 1986
- Decision Date
- August 10, 1987
- 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 Carolina Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K914200 | VASCUMAP MEDICAL AIR PLETHYSMOGRAPH | Nov 7, 1991 | Substantially Equivalent |
| K874684 | TC2-64B TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K874685 | TRANS-SCAN 3-D TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K843891 | DOPSCAN PLUS DS1060 | Jan 9, 1985 | Substantially Equivalent |
| K837329 | SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND | Jun 7, 1983 | Substantially Equivalent |
| K820272 | CLINIFLOW II, #701, ELECTROMAGN. BLD. SY | Mar 12, 1982 | Substantially Equivalent |
| K810561 | DOPSCAN MODEL 1050 | Apr 10, 1981 | Substantially Equivalent |
| K801647 | SONACOLOR 6100 | Aug 20, 1980 | Substantially Equivalent |
| K792540 | SONACOLOR 6000 | Jan 17, 1980 | Substantially Equivalent |
| K772015 | PATIENT HEATER SYSTEM, MODEL PH112 | Nov 15, 1977 | Substantially Equivalent |