FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)— 510(k) K964055

Substantially Equivalent

Epic Medical Equipment Services, Inc.

FDA 510(k) clearance K964055 for FLEXI-SITE (E203-01)/ FLEXI-FIT (E300), Substantially Equivalent on 1997-02-21. Applicant: Epic Medical Equipment Services, Inc..

Clearance details

Applicant: Epic Medical Equipment Services, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1996-10-09
Decision date: 1997-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.