PORTABLE VENTILATOR, MODEL EPV-100— 510(k) K072214
Substantially EquivalentAllied Healthcare Products, Inc.
FDA 510(k) clearance K072214 for PORTABLE VENTILATOR, MODEL EPV-100, Substantially Equivalent on 2008-03-06. Applicant: Allied Healthcare Products, Inc..
Clearance details
- Applicant
- Allied Healthcare Products, Inc.
- Product code
- Code BTL
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Louis, MO, US
Adverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
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.