FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IBC VENT VALVE, MODEL 1400
K Number: K992964
·
Decision Nov 19, 1999
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
11
Review Days
78
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Basic Information
- Device Name
- IBC VENT VALVE, MODEL 1400
- K Number
- K992964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Biophysics Corp.
- Date Received
- September 2, 1999
- Decision Date
- November 19, 1999
- Product Code
- MNJ
- 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 |
|---|---|---|---|
| MNJ | Valve, Pressure Relief, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNJ), ordered by most recent decision date.
View allOther Clearances by International Biophysics Corp.
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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 |
| K983272 | IBC FLOPUMP, MODEL 6000 | Mar 24, 1999 | Substantially Equivalent |
| K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) | Apr 8, 1998 | 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 |