FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIKKISO NK PUMP
K Number: K920077
·
Decision Sep 29, 1993
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
14
Applicant Total
9
Review Days
630
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Basic Information
- Device Name
- NIKKISO NK PUMP
- K Number
- K920077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4430
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Medical Products, Inc.
- Date Received
- January 8, 1992
- Decision Date
- September 29, 1993
- Product Code
- DWD
- 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 |
|---|---|---|---|
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by International Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES | Jun 16, 1998 | Substantially Equivalent |
| K973253 | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE | Oct 30, 1997 | Substantially Equivalent |
| K971053 | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS | Jun 16, 1997 | Substantially Equivalent |
| K923942 | RHOMBO MEDICAL RHOMBO-FILL | Mar 24, 1993 | Substantially Equivalent |
| K900755 | DIGITAL CUFF PV GAUGE | Apr 26, 1990 | Substantially Equivalent |
| K864984 | ROBINJECT | Jun 29, 1987 | Substantially Equivalent |
| K863609 | SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 | Feb 25, 1987 | Substantially Equivalent |
| K861539 | NIKKISO INFUSION PUMP MODEL PFA-02 | Jul 31, 1986 | Substantially Equivalent |