FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL H 607-.67M2 30 MICRON RP AN69 MEM
K Number: K800536
·
Decision Aug 7, 1980
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
55
Review Days
150
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Basic Information
- Device Name
- MODEL H 607-.67M2 30 MICRON RP AN69 MEM
- K Number
- K800536
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Hospal Medical Corp.
- Date Received
- March 10, 1980
- Decision Date
- August 7, 1980
- 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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Other Clearances by Hospal Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K893742 | FILTRAL TM 20 HEMODIALYZER/FILTER | Jul 24, 1989 | Substantially Equivalent |
| K884365 | MULTIFLOW(TM) 60 KIT | Dec 8, 1988 | Substantially Equivalent |
| K884326 | FILTRAL TM 8 HEMODIALYZER | Dec 5, 1988 | Substantially Equivalent |
| K883307 | CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT | Oct 12, 1988 | Substantially Equivalent |
| K872767 | FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER | Dec 29, 1987 | Substantially Equivalent |
| K871218 | MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT | Apr 30, 1987 | Substantially Equivalent |
| K863961 | HOSPAL BIOSPAL 1800S | Dec 17, 1986 | Substantially Equivalent |
| K863592 | DISSCAP 80E, 110E, 140E, 160E | Sep 25, 1986 | Substantially Equivalent |
| K861156 | HOSPAL DIALYSATE FOR CAVHD | Sep 23, 1986 | Substantially Equivalent |
| K861230 | MONITRAL S | Apr 25, 1986 | Substantially Equivalent |