FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K Number: K963703
·
Decision Apr 8, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
11
Review Days
569
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Basic Information
- Device Name
- ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
- K Number
- K963703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Biophysics Corp.
- Date Received
- September 16, 1996
- Decision Date
- April 8, 1998
- Product Code
- DPT
- 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K030181 | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM | Apr 17, 2003 | Substantially Equivalent |
| K992657 | IBC VRV, MODEL 1350 | Feb 18, 2000 | Substantially Equivalent |
| K992785 | IBC FLOGUARD, MODEL 6050 | Jan 14, 2000 | Substantially Equivalent |
| K992964 | IBC VENT VALVE, MODEL 1400 | Nov 19, 1999 | Substantially Equivalent |
| K983272 | IBC FLOPUMP, MODEL 6000 | Mar 24, 1999 | Substantially Equivalent |
| K963756 | IBC CARDIAC SUCTION WARD | Nov 14, 1997 | Substantially Equivalent |
| K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | Mar 20, 1997 | Substantially Equivalent |
| K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) | May 14, 1996 | Substantially Equivalent |
| K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) | May 14, 1996 | Substantially Equivalent |