510(k) K971455
- Device
- CLARUS MODEL 5197 SIGHTLITE
- Applicant
- CLARUS MEDICAL SYSTEMS, INC.
- 510(k) number
- K971455
- Product code
- FTI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-20
- Date received
- 1997-04-21
- Regulation
- 876.1500
- Classification name
- Lamp, Endoscope, Incandescent
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE SAPPENFIELD
- Address
- 1000 Boone Ave. N. #100 Minneapolis MN US 55427 55427
FDA Registration Numbers#
- 2183911
Source Documents#
Other 510(k) Records For Product Code FTI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914397 | OXFORD OPTRONIX MPM 3S | Dia-Stron, Ltd. | 1992-11-16 |
Legacy Summary#
summary
FDA Review#
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