AS3700 ANESTHSIA DELIVERY SYSTEM— 510(k) K102471
Substantially EquivalentMindray DS USA, Inc.
FDA 510(k) clearance K102471 for AS3700 ANESTHSIA DELIVERY SYSTEM, Substantially Equivalent on 2011-02-11. Applicant: Mindray DS USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Mindray DS USA, Inc.
- Product code
- Code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mahwh, NJ, US
Recent devices under product code BSZ
view allMore clearances from Mindray DS USA, Inc.
view allAdverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K102471
K-number listed on FDA's recall record- Z-0290-2013 — Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
- Z-0291-2013 — Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102471.
Data sourced from openFDA. This site is unofficial and independent of the FDA.