CATSmart
FDA 510(k) clearance K160735 · decided 2016-09-16
Clearance details
- K-number
- K160735
- Device name
- CATSmart
- Applicant
- Fresenius Kabi AG
- Decision
- Substantially Equivalent
- Date received
- 2016-03-17
- Decision date
- 2016-09-16
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bad Homburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.