EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
FDA 510(k) clearance K190124 · decided 2019-10-20
Clearance details
- K-number
- K190124
- Device name
- EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
- Applicant
- E.M.S Electro Medical Systems S.A
- Decision
- Substantially Equivalent
- Date received
- 2019-01-25
- Decision date
- 2019-10-20
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Nyon, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Soft recall (Z-1686-2024) | Electro Medical Systems SA | 2024-04-24 |
| Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software recall (Z-1687-2024) | Electro Medical Systems SA | 2024-04-24 |
| Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Softwar recall (Z-1688-2024) | Electro Medical Systems SA | 2024-04-24 |