THE LUNG GYM (XLATOR AND NLATOR)— 510(k) K861564
Substantially EquivalentEl-Fax Company, Inc.
FDA 510(k) clearance K861564 for THE LUNG GYM (XLATOR AND NLATOR), Substantially Equivalent on 1986-08-07. Applicant: El-Fax Company, Inc.. Device class: 2.
Clearance details
- Applicant
- El-Fax Company, Inc.
- Product code
- Code BWF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ardmore, PA, US
Recent devices under product code BWF
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