ASTOTHERM PLUS, ASTOTUBES, ASTOLINE— 510(k) K991160

Name: FDA 510(k) clearance K991160
Creator: U.S. Food and Drug Administration
Published: 1999-09-02

Substantially Equivalent

Stihler Electronic GmbH

FDA 510(k) clearance K991160 for ASTOTHERM PLUS, ASTOTUBES, ASTOLINE, Substantially Equivalent on 1999-09-02. Applicant: Stihler Electronic GmbH. Device class: 2.

Clearance details

Applicant: Stihler Electronic GmbH
Product code: Code BSB
Device class: Class 2
Regulation: 21 CFR 864.9205
Advisory panel: Hematology
Date received: 1999-04-07
Decision date: 1999-09-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sound Beach, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSB

product code BSB

Death: 5
Malfunction: 1,778
Total: 1,783

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.