The following data is part of a premarket notification filed by Medical Diagnostics, Ca. with the FDA for Focuscope Universal System.
| Device ID | K843900 |
| 510k Number | K843900 |
| Device Name: | FOCUSCOPE UNIVERSAL SYSTEM |
| Classification | Endoscope, Fiber Optic |
| Applicant | MEDICAL DIAGNOSTICS, CA. 2004 KISER DRIVE Valrico , FL 33594 - |
| Contact | Paul Butler |
| Correspondent | Paul Butler MEDICAL DIAGNOSTICS, CA. 2004 KISER DRIVE Valrico , FL 33594 - |
| Product Code | GDB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-03 |
| Decision Date | 1984-12-06 |