ROCKING/CIRCULATING CYTO-THERM II 3570
FDA 510(k) clearance K813489 · decided 1982-03-04
Clearance details
- K-number
- K813489
- Device name
- ROCKING/CIRCULATING CYTO-THERM II 3570
- Applicant
- Cryosan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-01
- Decision date
- 1982-03-04
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- KZL
- Device class
- 2
- Regulation number
- 864.9205
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CIRCULATING CYTO-THERMS (K812311) | Cryosan, Inc. | 1981-09-16 |
| FLO TEM (FLUID WARNER) (K800699) | Chroma Products, Inc. | 1980-05-08 |
| MODEL 114 TREONIC H150 HAEMOHEATER (K790936) | Vickers America Medical Corp. | 1979-09-04 |
Recalls involving this device
No recalls on record reference this clearance.