MECONIUM SUCTION TRAP— 510(k) K862181
Substantially EquivalentMichael Reese Hospital and Medical Center
FDA 510(k) clearance K862181 for MECONIUM SUCTION TRAP, Substantially Equivalent on 1986-08-13. Applicant: Michael Reese Hospital and Medical Center.
Clearance details
- Applicant
- Michael Reese Hospital and Medical Center
- Product code
- Code BSY
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Adverse events under product code BSY
product code BSY- Death
- 3
- Injury
- 155
- Malfunction
- 959
- Total
- 1,117
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.