M5T INSTANT FEVER THERMOMETER— 510(k) K012217
Substantially EquivalentMedisim, Ltd.
FDA 510(k) clearance K012217 for M5T INSTANT FEVER THERMOMETER, Substantially Equivalent on 2001-08-01. Applicant: Medisim, Ltd.. Device class: 2.
Clearance details
- Applicant
- Medisim, Ltd.
- 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
- Ra'Ananna, IL
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More clearances from Medisim, Ltd.
view allAdverse 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.