PRESSURE TURING AND ACCESSORIES— 510(k) K925918
Substantially EquivalentApplied Medical Resources
FDA 510(k) clearance K925918 for PRESSURE TURING AND ACCESSORIES, Substantially Equivalent on 1993-02-12. Applicant: Applied Medical Resources.
Clearance details
- Applicant
- Applied Medical Resources
- Product code
- Code GCM
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Launa Hills, CA, US
Adverse events under product code GCM
product code GCM- Malfunction
- 1,233
- Total
- 1,233
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.