731 Series Ventilators— 510(k) K162832
Substantially EquivalentZOLL Medical Corporation
FDA 510(k) clearance K162832 for 731 Series Ventilators, Substantially Equivalent on 2017-08-02. Applicant: ZOLL Medical Corporation. Device class: 2.
Clearance details
- Applicant
- ZOLL Medical Corporation
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chelsmford, MA, US
Recent devices under product code CBK
view allMore clearances from ZOLL Medical Corporation
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 K162832
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162832.
Data sourced from openFDA. This site is unofficial and independent of the FDA.