XENON LIGHT SOURCE, MODELS LS6180, LS6035— 510(k) K982962
Substantially EquivalentContec Medical Vision, Ltd.
FDA 510(k) clearance K982962 for XENON LIGHT SOURCE, MODELS LS6180, LS6035, Substantially Equivalent on 1998-09-23. Applicant: Contec Medical Vision, Ltd..
Clearance details
- Applicant
- Contec Medical Vision, Ltd.
- Product code
- Code GCT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fallston,, MD, US
Adverse events under product code GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.