ONEVIEW INTERFACE
FDA 510(k) clearance K040074 · decided 2004-04-08
Clearance details
- K-number
- K040074
- Device name
- ONEVIEW INTERFACE
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-14
- Decision date
- 2004-04-08
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FKP
- 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
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Recalls involving this device
No recalls on record reference this clearance.