STIMRITE
FDA 510(k) clearance K821691 · decided 1982-08-25
Clearance details
- K-number
- K821691
- Device name
- STIMRITE
- Applicant
- Biotone International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-08
- Decision date
- 1982-08-25
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- EPF
- Device class
- 2
- Regulation number
- 874.3320
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- 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 |
|---|---|---|
| HYPERSOUND AUDIO SYSTEM (HSS) (K133352) | Hypersound Health, Inc. | 2014-02-12 |
| TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (K982683) | Telex Communications, Inc. | 1998-10-06 |
| INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT (K974658) | Phonic Ear, Inc. | 1998-02-25 |
| FM RECEIVER - AUDITORY TRAINER (K974287) | Phonic Ear, Inc. | 1998-02-10 |
| WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970687) | Williams Sound, LLC | 1997-05-02 |
| WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970665) | Williams Sound, LLC | 1997-05-02 |
| HF MEGA EAR (K960567) | Maxi-Aids, Inc. | 1996-10-16 |
| GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (K950730) | Phonic Ear, Inc. | 1995-06-30 |
| PHONAK MICROVOX RESONAL FM SYSTEM (K941768) | Phonak, Inc. | 1994-06-24 |
| PHONIC EAR (K940313) | Phonic Ear, Inc. | 1994-03-22 |
| PE 400IR, PE 400T, PE 400E (K923234) | Phonic Ear, Inc. | 1992-09-29 |
| GROUP AUDITORY TRAINING SYSTEM (K922720) | Phonic Ear, Inc. | 1992-08-24 |
Recalls involving this device
No recalls on record reference this clearance.