Model FS1
FDA 510(k) K790481 · Starkey Laboratories, Inc.
510(k) numberK790481
Submission
- Device name
- Model FS1
- Applicant
- Starkey Laboratories, Inc.
Mchenry, IL, US - Received
- March 8, 1979
- Decision date
- April 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHL – Hearing Aid, Master
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3330
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KHL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964080 | Lori Hearing Aid SimulatorKHL · Traditional | Lori Medical Laboratories, Inc. | 01/08/1997SE |
| K911726 | Programmable Auditory Comparator, ModificationKHL · Traditional | Bausch & Lomb, Inc. | 10/23/1991SE |
| K894019 | Resound Demo. Behind-The-Ear Hrng., Model Demo BteKHL · Traditional | Resound Corp. | 09/21/1989SE |
| K860171 | Voroba Programmable Auditory ComparatorKHL · Traditional | Voroba Technologies Assoc. | 05/02/1986SE |
| K854126 | Craigwell Master Hearing Aid MhaKHL · Traditional | Craigwell Electronics, Ltd. | 01/16/1986SE |
| K802812 | Rionet Hearing AidKHL · Traditional | Kindel & Anderson | 11/26/1980SE |
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| 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 FS1 cleared by the FDA?
Model FS1 (K790481) received a 510(k) decision of Substantially Equivalent on April 3, 1979, 26 days after the submission was received.
What is the product code of K790481?
The FDA product code is KHL – Hearing Aid, Master, a Class II (moderate risk) device regulated under 21 CFR 874.3330.