STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR— 510(k) K973532

Substantially Equivalent

Dhd Diemolding Healthcare Div.

FDA 510(k) clearance K973532 for STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR, Substantially Equivalent on 1998-03-19. Applicant: Dhd Diemolding Healthcare Div..

Clearance details

Applicant: Dhd Diemolding Healthcare Div.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1997-09-18
Decision date: 1998-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wampsville, NY, 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.