CerroZone Mobile
FDA 510(k) clearance K220298 · decided 2022-07-01
Clearance details
- K-number
- K220298
- Device name
- CerroZone Mobile
- Applicant
- Cerrozone
- Decision
- Substantially Equivalent
- Date received
- 2022-02-02
- Decision date
- 2022-07-01
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- FRF
- Device class
- 2
- Regulation number
- 880.5045
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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| Qorda QD1 (K220990) | Winix, Inc. | 2022-09-14 |
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| AIRSONETT AIR-4 (K130702) | Airsonett AB | 2013-07-23 |
| HEPAIRX VENTILATING AIR PURIFIER (K112728) | Air Innovations, Inc. | 2013-01-23 |
| AIRSONNETT AIRSHOWER AIR 3 (K081062) | Airsonett, Inc. | 2008-11-07 |
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Recalls involving this device
No recalls on record reference this clearance.