PARAMEDIC O2 KIT— 510(k) K780168

Substantially Equivalent

Pohlmann Rescue Products, Inc.

FDA 510(k) clearance K780168 for PARAMEDIC O2 KIT, Substantially Equivalent on 1978-04-18. Applicant: Pohlmann Rescue Products, Inc..

Clearance details

Applicant: Pohlmann Rescue Products, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1978-02-02
Decision date: 1978-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.