0.2 U BACTERIAL FILTER— 510(k) K974661
Substantially EquivalentSims Deltec, Inc.
FDA 510(k) clearance K974661 for 0.2 U BACTERIAL FILTER, Substantially Equivalent on 1998-02-11. Applicant: Sims Deltec, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Deltec, Inc.
- Product code
- Code FPB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FPB
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Adverse events under product code FPB
product code FPB- Other
- 1
- Total
- 1
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.