SPIROS— 510(k) K915564

Substantially Equivalent

Life Support Products, Inc.

FDA 510(k) clearance K915564 for SPIROS, Substantially Equivalent on 1992-01-30. Applicant: Life Support Products, Inc..

Clearance details

Applicant: Life Support Products, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1991-12-12
Decision date: 1992-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.