MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR— 510(k) K111570

Substantially Equivalent

Thayer Medical Corporation

FDA 510(k) clearance K111570 for MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR, Substantially Equivalent on 2011-09-29. Applicant: Thayer Medical Corporation.

Clearance details

Applicant: Thayer Medical Corporation
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2011-06-06
Decision date: 2011-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.