BERNOULLI ENTERPRISE SOFTWARE
FDA 510(k) clearance K130208 · decided 2013-12-20
Clearance details
- K-number
- K130208
- Device name
- BERNOULLI ENTERPRISE SOFTWARE
- Applicant
- Cardiopulmonary Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-28
- Decision date
- 2013-12-20
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.