Evolv Model BP7000 Upper Arm Blood Pressure Monitor— 510(k) K162092
Substantially EquivalentOmron Healthcare, Inc.
FDA 510(k) clearance K162092 for Evolv Model BP7000 Upper Arm Blood Pressure Monitor, Substantially Equivalent on 2016-11-22. Applicant: Omron Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Omron Healthcare, Inc.
- Product code
- 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
- Lake Forest, IL, US
Recent devices under product code DXN
view all- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
- K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
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.