The following data is part of a premarket notification filed by Artiberia with the FDA for 1-100 Universal Set Otoscope & Larynx Exploraton B.
| Device ID | K851745 |
| 510k Number | K851745 |
| Device Name: | 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B |
| Classification | Otoscope |
| Applicant | ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Contact | Gil M Sanchez |
| Correspondent | Gil M Sanchez ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-25 |
| Decision Date | 1985-08-29 |