FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINIFLOW II, #701, ELECTROMAGN. BLD. SY
K Number: K820272
·
Decision Mar 12, 1982
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
11
Review Days
38
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Basic Information
- Device Name
- CLINIFLOW II, #701, ELECTROMAGN. BLD. SY
- K Number
- K820272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Carolina Medical Electronics
- Date Received
- February 2, 1982
- Decision Date
- March 12, 1982
- 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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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 |
| K864624 | PROBE, UPTAKE, NUCLEAR | Aug 10, 1987 | Substantially Equivalent |
| K843891 | DOPSCAN PLUS DS1060 | Jan 9, 1985 | Substantially Equivalent |
| K837329 | SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND | Jun 7, 1983 | 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 |