GENESIS BLS— 510(k) K983643

Substantially Equivalent

O-Two Systems Intl., Inc.

FDA 510(k) clearance K983643 for GENESIS BLS, Substantially Equivalent on 1998-10-29. Applicant: O-Two Systems Intl., Inc..

Clearance details

Applicant: O-Two Systems Intl., Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1998-10-16
Decision date: 1998-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, CA

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.