Level 1 Convective Warmer— 510(k) K181699
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K181699 for Level 1 Convective Warmer, Substantially Equivalent on 2018-07-26. Applicant: Smiths Medical Asd, Inc..
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code DWJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnepolis, MN, US
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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.