ABL5 BLOOD GAS SYSTEM; BPH5 BLOOD PH SYSTEM— 510(k) K943882
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K943882 for ABL5 BLOOD GAS SYSTEM; BPH5 BLOOD PH SYSTEM, Substantially Equivalent on 1995-03-10. Applicant: Radiometer America, Inc.. Device class: 2.
Clearance details
- Device name as filed
- ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
- Applicant
- Radiometer America, Inc.
- Product code
- Code CHL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1120
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
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Adverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
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.