ERA — Otoscope Class I
FDA product code ERA covers "Otoscope", a Class I medical device regulated under 21 CFR 874.4770. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ERA
- Device Class
- Class I
- Regulation Number
- 874.4770
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123821 | blue focus | AIO HD OTOSCOPE | May 17, 2013 |
| K121326 | lantos technologies | LANTOS 3D EAR SCANNER | January 25, 2013 |
| K110326 | osram sylvania | OSRAM ITOS | October 27, 2011 |
| K945264 | optus | OPTUS OTOSCOPES | February 2, 1996 |
| K955043 | welch allyn | WELCH ALLYN BI-OTOSCOPE | November 14, 1995 |
| K952578 | welch allyn | WELCH ALLY OTOSCOPE | July 10, 1995 |
| K950913 | rudolf riester gmbh and co. kg | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | May 12, 1995 |
| K950788 | neitz instruments company | OTOSCOPE A-34 | May 3, 1995 |
| K951049 | pedia pals | SPECULUM, ENT (S3) | April 17, 1995 |
| K951050 | pedia pals | SPECULUM, ENT (S3) | April 17, 1995 |
| K951255 | introspect | IMEDGE VIDEO OSTOSCOPE (ANALOG) | April 13, 1995 |
| K950983 | introspect | IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE | April 12, 1995 |
| K950787 | welch allyn | WELCH ALLYN OTOSCOPE | April 6, 1995 |
| K946043 | rudolf riester gmbh and co. kg | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG | March 8, 1995 |
| K943721 | smith and nephew | OTOVIEW TELESCOPIC OTOSCOPES | November 18, 1994 |
| K944897 | home care instruments | HOME CARE EAR EXAMINATIO KIT | November 8, 1994 |
| K943731 | cuda products | VIDEO OTOSCOPE | October 11, 1994 |
| K944031 | jedmed instrument | VIDEO SCOPE SYSTEM (OTOSCOPE) | September 23, 1994 |
| K943916 | welch allyn | VIDEOTOSCOPE | August 25, 1994 |
| K942244 | national custom ent | REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE | June 24, 1994 |