3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000— 510(k) K980089
Substantially EquivalentValley West, Inc.
FDA 510(k) clearance K980089 for 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000, Substantially Equivalent on 1998-03-24. Applicant: Valley West, Inc.. Device class: 2.
Clearance details
- Applicant
- Valley West, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Meridian, TX, US
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More clearances from Valley West, Inc.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.