NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM— 510(k) K082724
Substantially EquivalentNewport Medical Instruments, Inc.
FDA 510(k) clearance K082724 for NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM, Substantially Equivalent on 2008-12-16. Applicant: Newport Medical Instruments, Inc..
Clearance details
- Applicant
- Newport Medical Instruments, Inc.
- Product code
- Code CBK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.