UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR— 510(k) K951764
Substantially EquivalentPtw-New York Corp.
FDA 510(k) clearance K951764 for UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR, Substantially Equivalent on 1995-10-07. Applicant: Ptw-New York Corp.. Device class: 2.
Clearance details
- Applicant
- Ptw-New York Corp.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellmore, NY, US
Recent devices under product code IYE
view allMore clearances from Ptw-New York Corp.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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 →
Recalls naming K951764
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951764.
Data sourced from openFDA. This site is unofficial and independent of the FDA.