Patient Monitor, models LM-8, LM-10, LM-12 and LM-15— 510(k) K221879
Substantially EquivalentCaf Medical Solutions, Inc.
FDA 510(k) clearance K221879 for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15, Substantially Equivalent on 2022-08-10. Applicant: Caf Medical Solutions, Inc..
Clearance details
- Applicant
- Caf Medical Solutions, Inc.
- Product code
- Code MHX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hockley, TX, US
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.