S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)— 510(k) K955164

Substantially Equivalent

Habley Medical Technology Corp.

FDA 510(k) clearance K955164 for S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM), Substantially Equivalent on 1996-03-20. Applicant: Habley Medical Technology Corp..

Clearance details

Applicant: Habley Medical Technology Corp.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1995-11-13
Decision date: 1996-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.