FUKUDA DENSHI— 510(k) K103134
Substantially EquivalentFukuda Denshi USA, Inc.
FDA 510(k) clearance K103134 for FUKUDA DENSHI, Substantially Equivalent on 2011-03-11. Applicant: Fukuda Denshi USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Fukuda Denshi USA, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, WA, US
Recent devices under product code MHX
view allMore clearances from Fukuda Denshi USA, Inc.
view all- K173226 — CardiMax Electrocardiograph
- K150030 — Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
- K134046 — FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
- K112521 — FUKUDA DENSHI VASERA MODEL VS-1500
- K083697 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.