FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
FDA 510(k) clearance K070049 · decided 2011-02-03
Clearance details
- K-number
- K070049
- Device name
- FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2007-01-04
- Decision date
- 2011-02-03
- Days to decision
- 1491 days
- Clearance type
- Traditional
- Product code
- ONW
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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