MC-245, MC-246, MC-247, MC-341, MC-343, MC-344— 510(k) K091676
Substantially EquivalentOmron Healthcare, Inc.
FDA 510(k) clearance K091676 for MC-245, MC-246, MC-247, MC-341, MC-343, MC-344, Substantially Equivalent on 2009-09-01. Applicant: Omron Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Omron Healthcare, Inc.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
Recent devices under product code FLL
view all- K253162 — Temperature probes (5 models)
- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K250470 — Ear Thermometer (3 models)
- K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More clearances from Omron Healthcare, Inc.
view all- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- 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 FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
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.