NXSTAGE EXPRESS FLUID WARMER
FDA 510(k) clearance K140623 · decided 2014-06-16
Clearance details
- K-number
- K140623
- Device name
- NXSTAGE EXPRESS FLUID WARMER
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-11
- Decision date
- 2014-06-16
- Days to decision
- 97 days
- Clearance type
- Special
- Product code
- FLA
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lawrence, MA, 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 |
|---|---|---|
| FLUID WARMER (K842302) | Organon Teknika Corp. | 1984-08-27 |
| FLO-TEMP (K810021) | Laminar Flow Industries | 1981-01-23 |
Recalls involving this device
No recalls on record reference this clearance.