Model TM2-BEHIND-THE-EAR Tinnitus
FDA 510(k) K792214 · Starkey Laboratories, Inc.
510(k) numberK792214
Submission
- Device name
- Model TM2-BEHIND-THE-EAR Tinnitus
- Applicant
- Starkey Laboratories, Inc.
Mchenry, IL, US - Received
- November 2, 1979
- Decision date
- November 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K241152 | InSeeBWF · Traditional | Tidal Medical Technologies, LLC | 08/21/2025SE |
| K233855 | AllPEPBWF · Traditional | Enchant Tek Co. , Ltd. | 02/02/2024SE |
| K221058 | LungTrainer (MD2 & MD3)BWF · Traditional | Lung Trainers, LLC | 07/05/2023SE |
| K222018 | Breathe+BWF · Traditional | Peep Medical, LLC Dba Go2 Devices | 06/02/2023SE |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional | Medline Industries, Inc. | 10/25/2022SE |
| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | 06/19/2020SE |
| K122876 | Multiflex Tinnitus TechnologyKLW · Traditional | 10/31/2012SE |
| K030180 | Crescent Tinnitus Retaining Sound GeneratorKLW · Traditional | 09/17/2003SE |
| K970952 | Precise Impression KitESD · Traditional | 05/02/1997SE |
| K964245 | Precise, Tynmpanette, and Xacto Impression KitsESD · Traditional | 02/04/1997SE |
| K964340 | PORTAREM-3000, PFS-6000EWO · Traditional | 01/10/1997SE |
| K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerKLW · Traditional | 12/06/1996SE |
| K964244 | Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing AidsESD · Traditional | 11/27/1996SE |
| K964214 | Starkey A-13 Sequel Programmable, A-13 K-Amp Programmable Air Conduction Hearing AidsESD · Traditional | 11/27/1996SE |
| K963995 | Starkey MA-3 Air Conduction Combination Hearing Aid/Tinnitus MaskerKLW · Traditional | 11/26/1996SE |
Questions and answers
When was Model TM2-BEHIND-THE-EAR Tinnitus cleared by the FDA?
Model TM2-BEHIND-THE-EAR Tinnitus (K792214) received a 510(k) decision of Substantially Equivalent on November 27, 1979, 25 days after the submission was received.
What is the product code of K792214?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.