DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Aeromax Technologies, Inc.
Product code
Code CAF
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Phoenix, AZ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CAF

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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, 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.