SECOND WIND AIR PURIFIER
FDA 510(k) clearance K980745 · decided 1999-04-02
Clearance details
- K-number
- K980745
- Device name
- SECOND WIND AIR PURIFIER
- Applicant
- Monagan Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-26
- Decision date
- 1999-04-02
- Days to decision
- 400 days
- Clearance type
- Traditional
- Product code
- FRA
- Device class
- 2
- Regulation number
- 880.6500
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Albion, NY, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| Airgle Room Air Purifier (K232645) | Airgle Corporation | 2024-02-16 |
| Synexis Sphere Rx (K221540) | Synexis, LLC | 2023-06-14 |
| RGS; RGS Mini (K222702) | Genesis Air, Inc. | 2023-06-02 |
| Purgo (K223328) | Aeroclean Technologies, Inc. | 2022-11-30 |
| Purgo (K213753) | Aeroclean Technologies, LLC | 2022-06-01 |
| Aura Storm (K212644) | Invictus Lighting | 2022-05-26 |
| Bluezone Model RX-450 Air Purifier (K212824) | Bluezone Products, Inc. | 2022-02-17 |
| CUBE Air Purifier (K211139) | Samsung Electronics Co., Ltd. | 2021-11-26 |
Recalls involving this device
No recalls on record reference this clearance.