Starkey Laboratories Otoscope
FDA 510(k) K922752 · Starkey Laboratories, Inc.
510(k) numberK922752
Submission
- Device name
- Starkey Laboratories Otoscope
- Applicant
- Starkey Laboratories, Inc.
Eden Prairie, MN, US - Received
- June 8, 1992
- Decision date
- September 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ERA – Otoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4770
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ERA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123821 | Aio HD OtoscopeERA · Traditional | Blue Focus | 05/17/2013SE |
| K121326 | Lantos 3D Ear ScannerERA · Traditional | Lantos Technologies | 01/25/2013SE |
| K110326 | Osram ItosERA · Traditional | Osram Sylvania, Inc. | 10/27/2011SE |
| K945264 | Optus OtoscopesERA · Traditional | Optus, Inc. | 02/02/1996SE |
| K955043 | Welch Allyn Bi-OtoscopeERA · Traditional | Welch Allyn, Inc. | 11/14/1995SE |
| K952578 | Welch Ally OtoscopeERA · Traditional | Welch Allyn, Inc. | 07/10/1995SE |
| K950913 | Perfect, ENT Set, Praktikant, de LuxeERA · Traditional | Rudolf Riester GmbH & Co. KG | 05/12/1995SE |
| K950788 | Otoscope A-34ERA · Traditional | Neitz Instruments Company, Ltd. | 05/03/1995SE |
| K951050 | Speculum, ENT (S3)ERA · Traditional | Pedia Pals, Inc. | 04/17/1995SE |
| K951049 | Speculum, ENT (S3)ERA · Traditional | Pedia Pals, Inc. | 04/17/1995SE |
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|---|---|---|
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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 Starkey Laboratories Otoscope cleared by the FDA?
Starkey Laboratories Otoscope (K922752) received a 510(k) decision of Substantially Equivalent on September 4, 1992, 88 days after the submission was received.
What is the product code of K922752?
The FDA product code is ERA – Otoscope, a Class I (low risk) device regulated under 21 CFR 874.4770.