RESIDENT BEDSIDE MONITOR— 510(k) K811216
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K811216 for RESIDENT BEDSIDE MONITOR, Substantially Equivalent on 1981-07-02. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code DRT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
Adverse events under product code DRT
product code DRT- Death
- 4
- 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.