FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
K Number: K981003
·
Decision Jun 16, 1998
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
122
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
- K Number
- K981003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Medical Products, Inc.
- Date Received
- March 18, 1998
- Decision Date
- June 16, 1998
- Product Code
- KPO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by International Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K920077 | NIKKISO NK PUMP | Sep 29, 1993 | 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 |