OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N— 510(k) K042505
Substantially EquivalentOmron Healthcare, Inc.
FDA 510(k) clearance K042505 for OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N, Substantially Equivalent on 2005-04-05. Applicant: Omron Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Omron Healthcare, Inc.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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More clearances from Omron Healthcare, Inc.
view all- DEN230076 — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) +1 more
- K202228 — Omron Model BP7900 Blood Pressure Monitor + EKG
- K183215 — Focus TENS Therapy, Model PM710-M/-L
- K190693 — HEM-6410T-ZL Wrist Blood Pressure Monitor
- K182579 — Omron Model BP7900 Blood Pressure Monitor + EKG
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.