EARETTE HEARING AID SEARS #8054
FDA 510(k) clearance K810379 · decided 1981-03-04
Clearance details
- K-number
- K810379
- Device name
- EARETTE HEARING AID SEARS #8054
- Applicant
- Oticon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-13
- Decision date
- 1981-03-04
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- FSD
- Device class
- 1
- Regulation number
- 880.5160
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| THE POUCH GROIN & ABDOMINAL STRESS AID (K892379) | Kuhn Industries | 1989-07-20 |
| DOCE ALL-IN-THE-EAR AID (K822817) | Fidelty Hearing Instruments, Inc. | 1983-01-18 |
| MATERNITY SUPPORTER (K770162) | R.G. Moore | 1977-02-09 |
| DISPOSABLE ABDOMINAL BINDER (K760772) | Tecnol New Jersey Wound Care, Inc. | 1976-11-03 |
Recalls involving this device
No recalls on record reference this clearance.