RITEFLO SPACER— 510(k) K984085

Substantially Equivalent

Aeromax Technologies, Inc.

FDA 510(k) clearance K984085 for RITEFLO SPACER, Substantially Equivalent on 1999-08-05. Applicant: Aeromax Technologies, Inc..

Clearance details

Applicant: Aeromax Technologies, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1998-11-16
Decision date: 1999-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, 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.