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. Device class: 2.
Clearance details
- Applicant
- Applied Medical Resources
- Product code
- Code GCM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Launa Hills, CA, US
Recent devices under product code GCM
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- K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
- K001217 — INSIDE VIEW
- K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
- K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR
More clearances from Applied Medical Resources
view allAdverse 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.