MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter— 510(k) K233553

Substantially Equivalent

Thayer Medical Corporation

FDA 510(k) clearance K233553 for MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter, Substantially Equivalent on 2024-06-18. Applicant: Thayer Medical Corporation.

Clearance details

Applicant
Thayer Medical Corporation
Product code
Code CAF
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Tucson, AZ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAF

product code CAF
Death
22
Injury
125
Malfunction
613
Other
11
Total
771

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.