510(k) K840975— RICO RESPIRATION MONITOR
Substantially EquivalentJ.M. Laboratories, Inc.
Clearance details
- Applicant
- J.M. Laboratories, Inc.
- Product code
- Code BZK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code BZK
product code BZK- Death
- 2
- Total
- 2
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.