Submission Details
| 510(k) Number | K843900 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 1984 |
| Decision Date | December 06, 1984 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
FOCUSCOPE UNIVERSAL SYSTEM
Dec 1984
Decision
64d
Days
Class 2
Risk
About This 510(k) Submission
K843900 is an FDA 510(k) clearance for the FOCUSCOPE UNIVERSAL SYSTEM, a Endoscope, Fiber Optic (Class II — Special Controls, product code GDB), submitted by Medical Diagnostics, Ca. (Valrico, US). The FDA issued a Cleared decision on December 6, 1984, 64 days after receiving the submission on October 3, 1984. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | GDB — Endoscope, Fiber Optic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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