FOCUSCOPE UNIVERSAL SYSTEM
FDA 510(k) clearance K843900 · decided 1984-12-06
Clearance details
- K-number
- K843900
- Device name
- FOCUSCOPE UNIVERSAL SYSTEM
- Applicant
- Medical Diagnostics, Ca.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-03
- Decision date
- 1984-12-06
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- GDB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Valrico, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DESIGNS FOR VISION FIBEROPTIC LIGHT (K032283) | Designs For Vision, Inc. | 2003-08-20 |
| FLEXSCOPE (K961536) | Matrix Medica, Inc. | 1996-09-18 |
| ENDOSCOPE (K935818) | Cuda Products Co. | 1994-07-13 |
| OLYMPUS GF-UM3/EU-M3 (K882061) | Olympus Corp. | 1988-11-15 |
| FRITCH OPHTHALMIC ENDOSCOPE (K855151) | Regtec | 1986-02-19 |
| PENTAX UPPER G.I. FIBERSCOPE, #FG-34 (K810007) | Pentax Precision Instrument Corp. | 1981-01-15 |
Recalls involving this device
No recalls on record reference this clearance.