PHILIPS EASY DIAGNOST— 510(k) K970640
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K970640 for PHILIPS EASY DIAGNOST, Substantially Equivalent on 1997-03-21. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code IXR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1980
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code IXR
view allMore clearances from Philips Medical Systems North America, Inc.
view all- K102005 — ALLURA XPER OR TABLE SERIES
- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K050151 — MULTIDIAGNOST ELEVA
Recalls naming K970640
K-number listed on FDA's recall record- Z-2208-2012 — Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
- Z-1821-2012 — Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970640.
Data sourced from openFDA. This site is unofficial and independent of the FDA.