WELLHOFER WP700 V. 3.2— 510(k) K945321
Substantially EquivalentMedical Physics Instrumentation, Inc.
FDA 510(k) clearance K945321 for WELLHOFER WP700 V. 3.2, Substantially Equivalent on 1995-07-12. Applicant: Medical Physics Instrumentation, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Physics Instrumentation, Inc.
- 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
- Bartlett, TN, US
Recent devices under product code IYE
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 K945321
K-number listed on FDA's recall record- Z-2220-2017 — Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
- Z-0683-2016 — IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945321.
Data sourced from openFDA. This site is unofficial and independent of the FDA.