Imedge Digita Otoscope or Digital Video Otoscope
FDA 510(k) K950983 · Introspect, Inc.
510(k) numberK950983
Submission
- Device name
- Imedge Digita Otoscope or Digital Video Otoscope
- Applicant
- Introspect, Inc.
Excelsior, MN, US - Received
- March 3, 1995
- Decision date
- April 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
More from Pedia Pals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951255 | Imedge Video Ostoscope (Analog)ERA · Traditional | 04/13/1995SE |
Questions and answers
When was Imedge Digita Otoscope or Digital Video Otoscope cleared by the FDA?
Imedge Digita Otoscope or Digital Video Otoscope (K950983) received a 510(k) decision of Substantially Equivalent on April 12, 1995, 40 days after the submission was received.
What is the product code of K950983?
The FDA product code is ERA – Otoscope, a Class I (low risk) device regulated under 21 CFR 874.4770.