IONOMETER EH— 510(k) K901039
Substantially EquivalentFresenius USA, Inc.
FDA 510(k) clearance K901039 for IONOMETER EH, Substantially Equivalent on 1990-06-28. Applicant: Fresenius USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Fresenius USA, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
Recent devices under product code CEM
view allMore clearances from Fresenius USA, Inc.
view all- K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
- K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
- K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
- K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
- K961465 — 2008H ON LINE CLEARANCE MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.