Hydro-Temp Neonatal Skin Temperature Probe Cover— 510(k) K191425
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K191425 for Hydro-Temp Neonatal Skin Temperature Probe Cover, Substantially Equivalent on 2020-01-21. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, Inc.
- Product code
- Code FMT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5130
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Powell, TN, US
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Adverse events under product code FMT
product code FMT- Death
- 4
- Malfunction
- 3,074
- Total
- 3,078
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.