IMPACT MODEL 601— 510(k) K841537

Clearance details

Applicant

Impact Instrumentation, Inc.

Product code

Code BTI

Device class

Class 2

Regulation

21 CFR 868.6250

Advisory panel

Anesthesiology

Date received

1984-04-16

Decision date

1984-05-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K091238 — UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+2009-08-13
• K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV2008-12-10

Death

25

Malfunction

1,168

Total

1,193

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 →