Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)— 510(k) K223100
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K223100 for Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14), Substantially Equivalent on 2023-06-27. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
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Adverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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.