DRAGER MEDICAL AIR COMPRESSOR— 510(k) K951126

Substantially Equivalent

Drager, Inc.

FDA 510(k) clearance K951126 for DRAGER MEDICAL AIR COMPRESSOR, Substantially Equivalent on 1995-03-24. Applicant: Drager, Inc..

Clearance details

Applicant: Drager, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1995-03-13
Decision date: 1995-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

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.