ATS Thermal Imaging Probe, ATS Patient Interface Unit— 510(k) K180148
Substantially EquivalentSecurus Medical Group, Inc.
FDA 510(k) clearance K180148 for ATS Thermal Imaging Probe, ATS Patient Interface Unit, Substantially Equivalent on 2018-03-21. Applicant: Securus Medical Group, Inc.. Device class: 2.
Clearance details
- Applicant
- Securus Medical Group, 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
- Special
- Location
- Beverly, MA, US
Recent devices under product code FLL
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- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
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.