FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
K Number: K903641
·
Decision Nov 9, 1990
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
55
Review Days
87
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Basic Information
- Device Name
- QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
- K Number
- K903641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Bentley Laboratories, Inc.
- Date Received
- August 14, 1990
- Decision Date
- November 9, 1990
- Product Code
- KDI
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | Feb 28, 1990 | Substantially Equivalent |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Feb 2, 1988 | Substantially Equivalent |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | Feb 2, 1988 | Substantially Equivalent |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Jan 19, 1988 | Substantially Equivalent |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | Jan 5, 1983 | Substantially Equivalent |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | Jan 5, 1983 | Substantially Equivalent |
| K823456 | OXYGENATORS #BOS-10, 105, 5S | Dec 30, 1982 | Substantially Equivalent |