BACKPACK MEDICAL OXYGEN SYSTEM— 510(k) K071581
Substantially EquivalentEssex Cryogenics of Missouri, Inc.
FDA 510(k) clearance K071581 for BACKPACK MEDICAL OXYGEN SYSTEM, Substantially Equivalent on 2007-07-11. Applicant: Essex Cryogenics of Missouri, Inc..
Clearance details
- Applicant
- Essex Cryogenics of Missouri, Inc.
- Product code
- Code BYJ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Adverse events under product code BYJ
product code BYJ- Death
- 16
- Total
- 16
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.