ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
FDA 510(k) clearance K101831 · decided 2010-10-01
Clearance details
- K-number
- K101831
- Device name
- ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
- Applicant
- Bionostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-01
- Decision date
- 2010-10-01
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- OSL
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Devens, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.