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FDA 510(k)

HYPERQ AD-100 SYSTEM

K-Number: K102579 · 2010-12-02

ApplicantBiological Signal Processing, Ltd.
Decision Date2010-12-02
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYPERQ AD-100 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biological Signal Processing, Ltd.. It received FDA 510(k) clearance on 2010-12-02 under 510(k) number K102579. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERQ AD-100 SYSTEM?

HYPERQ AD-100 SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-02. The listed applicant is Biological Signal Processing, Ltd.. The 510(k) number is K102579.

When did HYPERQ AD-100 SYSTEM receive FDA 510(k) clearance?

HYPERQ AD-100 SYSTEM received FDA 510(k) clearance on 2010-12-02, under 510(k) number K102579.

Who is the listed applicant for HYPERQ AD-100 SYSTEM?

The FDA 510(k) record lists Biological Signal Processing, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERQ AD-100 SYSTEM?

The FDA product code for HYPERQ AD-100 SYSTEM is MWI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Biological Signal Processing, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082564HYPERQ SYSTEMK072389MODIFICATION TO HYPERQ SYSTEMK070624HYPERQ SYSTEMK042981HYPERQ SYSTEM

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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