BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.— 510(k) K863880
Substantially EquivalentD.R.G. Scientific Industries
FDA 510(k) clearance K863880 for BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD., Substantially Equivalent on 1986-11-24. Applicant: D.R.G. Scientific Industries.
Clearance details
- Applicant
- D.R.G. Scientific Industries
- Product code
- Code CHL
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Boston, MA, US
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.