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FDA 510(k)

INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)

K-Number: K941762 · 1995-02-22

ApplicantHogan & Hartson
Decision Date1995-02-22
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) is the device name listed in this FDA 510(k) record. The listed applicant is Hogan & Hartson. It received FDA 510(k) clearance on 1995-02-22 under 510(k) number K941762. 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 INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)?

INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is Hogan & Hartson. The 510(k) number is K941762.

When did INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) receive FDA 510(k) clearance?

INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) received FDA 510(k) clearance on 1995-02-22, under 510(k) number K941762.

Who is the listed applicant for INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)?

The FDA 510(k) record lists Hogan & Hartson as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)?

The FDA product code for INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) is DQK.

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Other records listing Hogan & Hartson 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.

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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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