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FDA 510(k)

PDS 9000 PATIENT DATA MGMT. SYSTEM

K-Number: K855055 · 1986-02-12

ApplicantMarquette Electronics, Inc.
Decision Date1986-02-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PDS 9000 PATIENT DATA MGMT. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K855055. 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 PDS 9000 PATIENT DATA MGMT. SYSTEM?

PDS 9000 PATIENT DATA MGMT. SYSTEM is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K855055.

When did PDS 9000 PATIENT DATA MGMT. SYSTEM receive FDA 510(k) clearance?

PDS 9000 PATIENT DATA MGMT. SYSTEM received FDA 510(k) clearance on 1986-02-12, under 510(k) number K855055.

Who is the listed applicant for PDS 9000 PATIENT DATA MGMT. SYSTEM?

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

What is the FDA product code for PDS 9000 PATIENT DATA MGMT. SYSTEM?

The FDA product code for PDS 9000 PATIENT DATA MGMT. SYSTEM is DQK.

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Other records listing Marquette Electronics, Inc. as applicant

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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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