INDEX SPO2 SIMULATOR— 510(k) K933519

Substantially Equivalent

Bio-Tek Instruments, Inc.

FDA 510(k) clearance K933519 for INDEX SPO2 SIMULATOR, Substantially Equivalent on 1994-09-01. Applicant: Bio-Tek Instruments, Inc..

Clearance details

Applicant: Bio-Tek Instruments, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1993-07-20
Decision date: 1994-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winooski, VT, 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.