ULTIMATE-AIRE— 510(k) K813258
Substantially EquivalentHawkins Intl.
FDA 510(k) clearance K813258 for ULTIMATE-AIRE, Substantially Equivalent on 1982-02-05. Applicant: Hawkins Intl.. Device class: 2.
Clearance details
- Applicant
- Hawkins Intl.
- Product code
- Code FRF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5045
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FRF
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