MCKESSON ANESTHESIA CARE
FDA 510(k) clearance K113633 · decided 2012-04-20
Clearance details
- K-number
- K113633
- Device name
- MCKESSON ANESTHESIA CARE
- Applicant
- Mckesson Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-08
- Decision date
- 2012-04-20
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Philedelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer recall (Z-1060-2014) | MCKESSON TECHNOLOGIES INC. | 2014-03-05 |