ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER— 510(k) K021124
Substantially EquivalentWfr/Aquaplast Corp.
FDA 510(k) clearance K021124 for ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER, Substantially Equivalent on 2002-07-02. Applicant: Wfr/Aquaplast Corp.. Device class: 2.
Clearance details
- Applicant
- Wfr/Aquaplast 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
- Wyckoff, NJ, US
Recent devices under product code IYE
view allMore clearances from Wfr/Aquaplast Corp.
view all- K120916 — QFIX RADIOTHERAPY CHAIR
- K060671 — KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
- K032156 — ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT
- K973370 — AQUAPLAST PALATAL STENT
- K943871 — AQUAPLAST TIE DOWN DRESSING
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.