FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSPAL 2400S
K Number: K834579
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
11
Applicant Total
55
Review Days
37
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Basic Information
- Device Name
- BIOSPAL 2400S
- K Number
- K834579
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Hospal Medical Corp.
- Date Received
- December 29, 1983
- Decision Date
- February 4, 1984
- Product Code
- KDT
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | FDA class 1 | Pathology |
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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 |