EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
FDA 510(k) clearance K073401 · decided 2008-03-14
Clearance details
- K-number
- K073401
- Device name
- EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
- Applicant
- Micromedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-04
- Decision date
- 2008-03-14
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- MJV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Earflo (EF001) (K252751) | Earflo, Inc. | 2026-02-10 |
| Ear Pressure Relief Device(Model:ER813B) (K230502) | Ningbo Albert Novosino Co., Ltd. | 2023-06-09 |
| Eustachi Ear Pressure Relief Device (K203754) | Exercore, LLC | 2021-02-19 |
| EARCLEAR (K951596) | Arisil Medical | 1995-05-24 |
| OTOVENT (K920840) | Abigo Medical AB | 1992-10-05 |
Recalls involving this device
No recalls on record reference this clearance.