FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Wrist Blood Pressure Monitor Model BP6100
K Number: K182127
·
Decision Nov 2, 2018
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
68
Review Days
88
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Basic Information
- Device Name
- Wrist Blood Pressure Monitor Model BP6100
- K Number
- K182127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omron Healthcare, Inc.
- Date Received
- August 6, 2018
- Decision Date
- November 2, 2018
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Omron Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | Oct 8, 2024 | Unknown |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Apr 1, 2021 | Substantially Equivalent |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | Sep 7, 2019 | Substantially Equivalent |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | Apr 17, 2019 | Substantially Equivalent |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Mar 14, 2019 | Substantially Equivalent |
| K182120 | Maxpower Relief | Jan 10, 2019 | Substantially Equivalent |
| K181992 | Heat Pain Pro | Nov 9, 2018 | Substantially Equivalent |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Nov 9, 2018 | Substantially Equivalent |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | Nov 8, 2018 | Substantially Equivalent |
| K172079 | Avail | Oct 19, 2017 | Substantially Equivalent |