CONDOR DIGITAL INFLATION SYRINGE— 510(k) K904954

Substantially Equivalent

Professional Medical Services

FDA 510(k) clearance K904954 for CONDOR DIGITAL INFLATION SYRINGE, Substantially Equivalent on 1991-01-16. Applicant: Professional Medical Services. Device class: 2.

Clearance details

Applicant
Professional Medical Services
Product code
Code MAV
Device class
Class 2
Regulation
21 CFR 870.1650
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Salt Lake, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MAV

product code MAV
Malfunction
1,433
Total
1,433

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.