BABI PLUS NEONATAL RESUSCITATION BAG— 510(k) K112852
Substantially EquivalentA Plus Medical
FDA 510(k) clearance K112852 for BABI PLUS NEONATAL RESUSCITATION BAG, Substantially Equivalent on 2012-01-13. Applicant: A Plus Medical.
Clearance details
- Applicant
- A Plus Medical
- Product code
- Code BTM
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Adverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
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.