COMP A-I-R— 510(k) K141140
Substantially EquivalentOmron Healthcare, Inc.
FDA 510(k) clearance K141140 for COMP A-I-R, Substantially Equivalent on 2014-09-30. Applicant: Omron Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Omron Healthcare, Inc.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
Recent devices under product code CAF
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- 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
Adverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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.