510(k) K861564— THE LUNG GYM (XLATOR AND NLATOR)
Substantially EquivalentEl-Fax Company, Inc.
Clearance details
- Applicant
- El-Fax Company, Inc.
- Product code
- Code BWF
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ardmore, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.