DINAMAP VITAL SIGNS MONITOR, MODEL 8100T— 510(k) K874378
Substantially EquivalentCritikon Company, LLC
FDA 510(k) clearance K874378 for DINAMAP VITAL SIGNS MONITOR, MODEL 8100T, Substantially Equivalent on 1987-12-30. Applicant: Critikon Company, LLC. Device class: 2.
Clearance details
- Applicant
- Critikon Company, LLC
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Recent devices under product code DXN
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More clearances from Critikon Company, LLC
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.