IONOMETER EF-HK AND ACCESSORIES— 510(k) K901042
Substantially EquivalentFresenius USA, Inc.
FDA 510(k) clearance K901042 for IONOMETER EF-HK AND ACCESSORIES, Substantially Equivalent on 1990-07-31. Applicant: Fresenius USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Fresenius USA, Inc.
- Product code
- Code JGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
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Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
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.