DANA EMULATING INDICATOR
FDA 510(k) clearance K100891 · decided 2011-01-13
Clearance details
- K-number
- K100891
- Device name
- DANA EMULATING INDICATOR
- Applicant
- Dana Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-31
- Decision date
- 2011-01-13
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- South Barrington, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.