BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS— 510(k) K083507
Substantially EquivalentAllied Healthcare Products, Inc.
FDA 510(k) clearance K083507 for BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS, Substantially Equivalent on 2009-05-18. 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.