RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE— 510(k) K780381

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K780381 for RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE, Substantially Equivalent on 1978-05-16. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 1978-03-10
Decision date: 1978-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.