Aespire View
FDA 510(k) clearance K143530 · decided 2015-04-24
Clearance details
- K-number
- K143530
- Device name
- Aespire View
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-12
- Decision date
- 2015-04-24
- Days to decision
- 133 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE recall (Z-0677-2016) | GE Medical Systems, LLC | 2016-01-21 |