PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007— 510(k) K012974
Substantially EquivalentPrizm Medical, Inc.
FDA 510(k) clearance K012974 for PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007, Substantially Equivalent on 2002-07-23. Applicant: Prizm Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Prizm Medical, 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
- Dunwoody, GA, US
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More clearances from Prizm Medical, Inc.
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.