RESPIRATOR MONITOR— 510(k) K813198
Substantially EquivalentFlorida Medical Equipment Repair, Inc.
FDA 510(k) clearance K813198 for RESPIRATOR MONITOR, Substantially Equivalent on 1981-12-08. Applicant: Florida Medical Equipment Repair, Inc..
Clearance details
- Applicant
- Florida Medical Equipment Repair, Inc.
- Product code
- Code CCL
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code CCL
product code CCL- Other
- 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.