RECON-2 FLOW CONTROLLER— 510(k) K834260
Substantially EquivalentPrecision Metering, Inc.
FDA 510(k) clearance K834260 for RECON-2 FLOW CONTROLLER, Substantially Equivalent on 1984-01-10. Applicant: Precision Metering, Inc..
Clearance details
- Applicant
- Precision Metering, Inc.
- Product code
- Code CAX
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code CAX
product code CAX- Death
- 3
- Other
- 1
- Total
- 4
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.