IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING— 510(k) K940425

Substantially Equivalent

Imagyn Medical, Inc.

FDA 510(k) clearance K940425 for IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING, Substantially Equivalent on 1994-08-01. Applicant: Imagyn Medical, Inc..

Clearance details

Applicant: Imagyn Medical, Inc.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1994-01-31
Decision date: 1994-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

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Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.