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FDA 510(k)

PORTABLE ECSCOPE 12I

K-Number: K080036 · 2008-01-16

ApplicantDyansys, Inc.
Decision Date2008-01-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PORTABLE ECSCOPE 12I is the device name listed in this FDA 510(k) record. The listed applicant is Dyansys, Inc.. It received FDA 510(k) clearance on 2008-01-16 under 510(k) number K080036. 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 PORTABLE ECSCOPE 12I?

PORTABLE ECSCOPE 12I is a medical device that received FDA 510(k) clearance on 2008-01-16. The listed applicant is Dyansys, Inc.. The 510(k) number is K080036.

When did PORTABLE ECSCOPE 12I receive FDA 510(k) clearance?

PORTABLE ECSCOPE 12I received FDA 510(k) clearance on 2008-01-16, under 510(k) number K080036.

Who is the listed applicant for PORTABLE ECSCOPE 12I?

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 PORTABLE ECSCOPE 12I?

The FDA product code for PORTABLE ECSCOPE 12I 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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