PULMONAIR 40 PATIENT MANAGEMENT SYSTEM— 510(k) K901295

Substantially Equivalent

The Medical Group, Inc.

FDA 510(k) clearance K901295 for PULMONAIR 40 PATIENT MANAGEMENT SYSTEM, Substantially Equivalent on 1990-03-30. Applicant: The Medical Group, Inc..

Clearance details

Applicant: The Medical Group, Inc.
Product code: Code IOQ
Advisory panel: Physical Medicine
Date received: 1990-03-20
Decision date: 1990-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buena Park, CA, US

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Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.