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FDA 510(k)

ECSCOPE 200

K-Number: K091397 · 2009-07-08

ApplicantDyansys, Inc.
Decision Date2009-07-08
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECSCOPE 200 is the device name listed in this FDA 510(k) record. The listed applicant is Dyansys, Inc.. It received FDA 510(k) clearance on 2009-07-08 under 510(k) number K091397. 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 ECSCOPE 200?

ECSCOPE 200 is a medical device that received FDA 510(k) clearance on 2009-07-08. The listed applicant is Dyansys, Inc.. The 510(k) number is K091397.

When did ECSCOPE 200 receive FDA 510(k) clearance?

ECSCOPE 200 received FDA 510(k) clearance on 2009-07-08, under 510(k) number K091397.

Who is the listed applicant for ECSCOPE 200?

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

What is the FDA product code for ECSCOPE 200?

The FDA product code for ECSCOPE 200 is DPS.

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Other records listing Dyansys, 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.

K221425Primary ReliefK221231Drug Relief v1K220397ANSiStim-PPK213188Primary ReliefK212859First ReliefK211971Drug Relief v1

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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

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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