OXYGEN THERAPY REGULATOR— 510(k) K894302
Substantially EquivalentModern Engineering Co., Inc.
FDA 510(k) clearance K894302 for OXYGEN THERAPY REGULATOR, Substantially Equivalent on 1989-08-07. Applicant: Modern Engineering Co., Inc..
Clearance details
- Applicant
- Modern Engineering Co., Inc.
- Product code
- Code CAN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Adverse events under product code CAN
product code CAN- Death
- 4
- Other
- 1
- Total
- 5
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.