VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.— 510(k) K954710
Substantially EquivalentNorthgate Technologies, Inc.
FDA 510(k) clearance K954710 for VAPOR-TECH ROLLER BALL ELECTRODE 24 FR., Substantially Equivalent on 1996-04-24. Applicant: Northgate Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Northgate Technologies, Inc.
- Product code
- Code FAS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elgin, IL, US
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More clearances from Northgate Technologies, Inc.
view allAdverse events under product code FAS
product code FAS- Death
- 3
- Injury
- 344
- Malfunction
- 1,130
- Total
- 1,477
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.