SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II— 510(k) K894103
Substantially EquivalentScimed Life Systems, Inc.
FDA 510(k) clearance K894103 for SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II, Substantially Equivalent on 1989-09-21. Applicant: Scimed Life Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Scimed Life Systems, Inc.
- Product code
- Code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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More clearances from Scimed Life Systems, Inc.
view allAdverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
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.