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FDA 510(k)

SPACELABS MEDICAL ECG ANALYSIS SYSTEM

K-Number: K962930 · 1997-04-25

ApplicantSpacelabs Medical, Inc.
Decision Date1997-04-25
Product CodeDQK
Advisory CommitteeCV
DecisionUnknown

Device Summary

SPACELABS MEDICAL ECG ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Medical, Inc.. It received FDA 510(k) clearance on 1997-04-25 under 510(k) number K962930. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SPACELABS MEDICAL ECG ANALYSIS SYSTEM?

SPACELABS MEDICAL ECG ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-25. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K962930.

When did SPACELABS MEDICAL ECG ANALYSIS SYSTEM receive FDA 510(k) clearance?

SPACELABS MEDICAL ECG ANALYSIS SYSTEM received FDA 510(k) clearance on 1997-04-25, under 510(k) number K962930.

Who is the listed applicant for SPACELABS MEDICAL ECG ANALYSIS SYSTEM?

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

What is the FDA product code for SPACELABS MEDICAL ECG ANALYSIS SYSTEM?

The FDA product code for SPACELABS MEDICAL ECG ANALYSIS SYSTEM is DQK.

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Other records listing Spacelabs Medical, 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.

K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)K102422SPACELABS MEDICAL PATIENT MONITORSK093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

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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

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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