AS3700 ANESTHSIA DELIVERY SYSTEM
FDA 510(k) clearance K102471 · decided 2011-02-11
Clearance details
- K-number
- K102471
- Device name
- AS3700 ANESTHSIA DELIVERY SYSTEM
- Applicant
- Mindray DS USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-30
- Decision date
- 2011-02-11
- Days to decision
- 165 days
- Clearance type
- Abbreviated
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mahwh, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 Ma recall (Z-0290-2013) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2012-11-16 |
| Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 Ma recall (Z-0291-2013) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2012-11-16 |