Carestation 620/650/650C
FDA 510(k) clearance K151570 · decided 2016-01-21
Clearance details
- K-number
- K151570
- Device name
- Carestation 620/650/650C
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-06-10
- Decision date
- 2016-01-21
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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