I22 Initiales
FDA 510(k) K862621 · Oticon Corp.
510(k) numberK862621
Submission
- Device name
- I22 Initiales
- Applicant
- Oticon Corp.
Somerset, NJ, US - Received
- July 10, 1986
- Decision date
- August 1, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Pedia Pals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973886 | Oticon Digisound CompactESD · Traditional | 11/04/1997SE |
| K973885 | Oticon Digisound IteESD · Traditional | 11/04/1997SE |
| K964683 | Digifocus IteESD · Traditional | 12/12/1996SE |
| K963788 | Primofocus CompactESD · Traditional | 11/27/1996SE |
| K961059 | Digifocus CompactESD · Traditional | 05/07/1996SE |
| K960284 | Oticon /Primofocus (PF)ESD · Traditional | 03/07/1996SE |
| K954794 | OticonESD · Traditional | 11/13/1995SE |
| K950381 | Oticon/LogicESD · Traditional | 02/27/1995SE |
| K946045 | OticonESD · Traditional | 01/30/1995SE |
| K933307 | Multifocus Compact Bte Hearing AidESD · Traditional | 08/23/1993SE |
Questions and answers
When was I22 Initiales cleared by the FDA?
I22 Initiales (K862621) received a 510(k) decision of Substantially Equivalent on August 1, 1986, 22 days after the submission was received.
What is the product code of K862621?
The FDA product code is ERA – Otoscope, a Class I (low risk) device regulated under 21 CFR 874.4770.