UltraEzAir® (UEA1A)
FDA 510(k) clearance K240114 · decided 2024-10-16
Clearance details
- K-number
- K240114
- Device name
- UltraEzAir® (UEA1A)
- Applicant
- Dualams, Inc., Dba Airkor
- Decision
- Substantially Equivalent
- Date received
- 2024-01-16
- Decision date
- 2024-10-16
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- CCT
- Device class
- 2
- Regulation number
- 868.5170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| Medicant Mucosal Atomizer (K172956) | Medica Holdings, LLC | 2018-04-06 |
| MADgic Laryngo-Tracheal Mucosal Atomization Device (K153470) | Teleflex Medical | 2016-08-19 |
| EZ-MISTER (K093584) | N.M. Beale Co., Inc. | 2011-03-04 |
| TOPICAL APPLICATOR (K070596) | Sharn, Inc. | 2007-06-21 |
| LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (K002255) | Wolfe Tory Medical, Inc. | 2000-09-18 |
| ASTRA DISPOSABLE SPRAY CANNULA (K894755) | Astra Pharmaceutical Products, Inc. | 1990-01-12 |
| ENDO-MED TUBE FOR ENDOTRACHEAL MED (K810059) | Ackrad Laboratories | 1981-02-26 |
| ANESTHESIA KIT (K760759) | Sherwood Medical Industries | 1976-12-09 |
| MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT (K760877) | Sherwood Medical Industries | 1976-12-09 |
Recalls involving this device
No recalls on record reference this clearance.