1-100 Universal Set Otoscope & Larynx Exploraton B
FDA 510(k) K851745 · Artiberia
510(k) numberK851745
Submission
- Device name
- 1-100 Universal Set Otoscope & Larynx Exploraton B
- Applicant
- Artiberia
San Antonio, TX, US - Received
- April 25, 1985
- Decision date
- August 29, 1985
- 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 |
|---|---|---|
| K851786 | 27-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional | 07/09/1985SE |
| K851730 | 2710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional | 07/02/1985SE |
| K851729 | 2620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional | 07/02/1985SE |
| K851727 | 2020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional | 07/02/1985SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | 07/02/1985SE |
| K851724 | 1410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional | 07/02/1985SE |
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | 07/02/1985SE |
| K851722 | 1285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional | 07/02/1985SE |
| K851721 | 1200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional | 07/02/1985SE |
| K851720 | 1155/1 to 1162/12 Various Types Gum ScissorsEGN · Traditional | 07/02/1985SE |
Questions and answers
When was 1-100 Universal Set Otoscope & Larynx Exploraton B cleared by the FDA?
1-100 Universal Set Otoscope & Larynx Exploraton B (K851745) received a 510(k) decision of Substantially Equivalent on August 29, 1985, 126 days after the submission was received.
What is the product code of K851745?
The FDA product code is ERA – Otoscope, a Class I (low risk) device regulated under 21 CFR 874.4770.