ERA — Otoscope Class I
FDA Device Classification
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 |
| K951050 | pedia pals | SPECULUM, ENT (S3) | April 17, 1995 |
| K951049 | 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 |