CIRCULATING CYTO-THERMS
FDA 510(k) clearance K812311 · decided 1981-09-16
Clearance details
- K-number
- K812311
- Device name
- CIRCULATING CYTO-THERMS
- Applicant
- Cryosan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-08-17
- Decision date
- 1981-09-16
- Days to decision
- 30 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
+ Add to Predicate Builder ◉ Watch Cryosan
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ROCKING/CIRCULATING CYTO-THERM II 3570 (K813489) | Cryosan, Inc. | 1982-03-04 |
| 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.