LIFEBORNE INFANT RESUSCITATOR— 510(k) K140707
Substantially EquivalentInternational Biomedical
FDA 510(k) clearance K140707 for LIFEBORNE INFANT RESUSCITATOR, Substantially Equivalent on 2014-05-28. Applicant: International Biomedical. Device class: 2.
Clearance details
- Applicant
- International Biomedical
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code BTL
view allMore clearances from International Biomedical
view allAdverse 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.