FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCKING/CIRCULATING CYTO-THERM II 3570
K Number: K813489
·
Decision Mar 4, 1982
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
3
Applicant Total
6
Review Days
93
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Basic Information
- Device Name
- ROCKING/CIRCULATING CYTO-THERM II 3570
- K Number
- K813489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9205
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Cryosan, Inc.
- Date Received
- December 1, 1981
- Decision Date
- March 4, 1982
- Product Code
- KZL
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KZL | Device, Warming. Blood And Plasma | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZL), ordered by most recent decision date.
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Other Clearances by Cryosan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K831953 | INFUSION PUMP | Jul 19, 1983 | Substantially Equivalent |
| K830831 | AUTOMATED BLOOD CELL SEPARATOR | Jun 16, 1983 | Substantially Equivalent |
| K822521 | AUTOMATED BLOOD CELL SEPARATOR | Sep 30, 1982 | Substantially Equivalent |
| K812309 | CRYOSAN NORMAL SALINE | Sep 16, 1981 | Substantially Equivalent |
| K812311 | CIRCULATING CYTO-THERMS | Sep 16, 1981 | Substantially Equivalent |