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FDA 510(k)

HOLTER FOR WINDOWS

K-Number: K930564 · 1995-04-19

ApplicantNorth East Monitoring, Inc.
Decision Date1995-04-19
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER FOR WINDOWS is the device name listed in this FDA 510(k) record. The listed applicant is North East Monitoring, Inc.. It received FDA 510(k) clearance on 1995-04-19 under 510(k) number K930564. 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 HOLTER FOR WINDOWS?

HOLTER FOR WINDOWS is a medical device that received FDA 510(k) clearance on 1995-04-19. The listed applicant is North East Monitoring, Inc.. The 510(k) number is K930564.

When did HOLTER FOR WINDOWS receive FDA 510(k) clearance?

HOLTER FOR WINDOWS received FDA 510(k) clearance on 1995-04-19, under 510(k) number K930564.

Who is the listed applicant for HOLTER FOR WINDOWS?

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

What is the FDA product code for HOLTER FOR WINDOWS?

The FDA product code for HOLTER FOR WINDOWS is DQK.

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Other records listing North East Monitoring, 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.

K081861HOLTER LX ANALYSISK070014AUTO DETECT FOR TELAHEART DR200/E-AK061293TELAHEART DIGITAL RECORDERK041901SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDERK004007DR180+OXYK001288DR180-II

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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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