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FDA 510(k)

QRS-CARD CARDIOLOGY SUITE

K-Number: K042799 · 2004-10-22

ApplicantPulse Biomedical, Inc.
Decision Date2004-10-22
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QRS-CARD CARDIOLOGY SUITE is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Biomedical, Inc.. It received FDA 510(k) clearance on 2004-10-22 under 510(k) number K042799. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QRS-CARD CARDIOLOGY SUITE?

QRS-CARD CARDIOLOGY SUITE is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is Pulse Biomedical, Inc.. The 510(k) number is K042799.

When did QRS-CARD CARDIOLOGY SUITE receive FDA 510(k) clearance?

QRS-CARD CARDIOLOGY SUITE received FDA 510(k) clearance on 2004-10-22, under 510(k) number K042799.

Who is the listed applicant for QRS-CARD CARDIOLOGY SUITE?

The FDA 510(k) record lists Pulse Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QRS-CARD CARDIOLOGY SUITE?

The FDA product code for QRS-CARD CARDIOLOGY SUITE is DQK.

Related Clinical Trials

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Other records listing Pulse Biomedical, Inc. 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.

K100813QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USBK972255PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Official Source

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

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