RESTRAINT, PROTECTIVE N0. 103— 510(k) K924566

Substantially Equivalent

Ansley Medical Products, Inc.

FDA 510(k) clearance K924566 for RESTRAINT, PROTECTIVE N0. 103, Substantially Equivalent on 1992-11-23. Applicant: Ansley Medical Products, Inc..

Clearance details

Applicant: Ansley Medical Products, Inc.
Product code: Code KMK
Advisory panel: General Hospital
Date received: 1992-09-09
Decision date: 1992-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.