3M Bair Hugger Temperature Management System (Model 675)— 510(k) K210603
Substantially Equivalent3M Company
FDA 510(k) clearance K210603 for 3M Bair Hugger Temperature Management System (Model 675), Substantially Equivalent on 2021-03-30. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
Recent devices under product code DWJ
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- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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.