HYPERQ SYSTEM— 510(k) K070624

Name: FDA 510(k) clearance K070624
Creator: U.S. Food and Drug Administration
Published: 2007-04-06

Substantially Equivalent

Biological Signal Processing, Ltd.

FDA 510(k) clearance K070624 for HYPERQ SYSTEM, Substantially Equivalent on 2007-04-06. Applicant: Biological Signal Processing, Ltd.. Device class: 2.

Clearance details

Applicant: Biological Signal Processing, Ltd.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2007-03-06
Decision date: 2007-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerset, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biological Signal Processing, Ltd.

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K102579 — HYPERQ AD-100 SYSTEM2010-12-02
K082564 — HYPERQ SYSTEM2008-10-20
K072389 — MODIFICATION TO HYPERQ SYSTEM2007-09-18
K042981 — HYPERQ SYSTEM2005-03-10

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.