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FDA 510(k)

VICOR PD2I ANALYZER

K-Number: K101867 · 2011-04-14

ApplicantVicor Technologies, Inc.
Decision Date2011-04-14
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VICOR PD2I ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Vicor Technologies, Inc.. It received FDA 510(k) clearance on 2011-04-14 under 510(k) number K101867. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VICOR PD2I ANALYZER?

VICOR PD2I ANALYZER is a medical device that received FDA 510(k) clearance on 2011-04-14. The listed applicant is Vicor Technologies, Inc.. The 510(k) number is K101867.

When did VICOR PD2I ANALYZER receive FDA 510(k) clearance?

VICOR PD2I ANALYZER received FDA 510(k) clearance on 2011-04-14, under 510(k) number K101867.

Who is the listed applicant for VICOR PD2I ANALYZER?

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

What is the FDA product code for VICOR PD2I ANALYZER?

The FDA product code for VICOR PD2I ANALYZER is DPS.

Related Clinical Trials

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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Other records listing Vicor Technologies, 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.

K082709VICOR PD2I ANALYZER, VERSION 2.1

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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