ULTIMATE-AIRE
FDA 510(k) clearance K813258 · decided 1982-02-05
Clearance details
- K-number
- K813258
- Device name
- ULTIMATE-AIRE
- Applicant
- Hawkins Intl.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-19
- Decision date
- 1982-02-05
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- FRF
- Device class
- 2
- Regulation number
- 880.5045
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.