FLO-TEMP
FDA 510(k) clearance K810021 · decided 1981-01-23
Clearance details
- K-number
- K810021
- Device name
- FLO-TEMP
- Applicant
- Laminar Flow Industries
- Decision
- Substantially Equivalent
- Date received
- 1981-01-05
- Decision date
- 1981-01-23
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- FLA
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| NXSTAGE EXPRESS FLUID WARMER (K140623) | Nxstage Medical, Inc. | 2014-06-16 |
| FLUID WARMER (K842302) | Organon Teknika Corp. | 1984-08-27 |
Recalls involving this device
No recalls on record reference this clearance.