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FDA 510(k)

PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)

K-Number: K082312 · 2008-09-12

ApplicantHeartscape Technologies, Ltd.
Decision Date2008-09-12
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) is the device name listed in this FDA 510(k) record. The listed applicant is Heartscape Technologies, Ltd.. It received FDA 510(k) clearance on 2008-09-12 under 510(k) number K082312. 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 PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)?

PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Heartscape Technologies, Ltd.. The 510(k) number is K082312.

When did PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) receive FDA 510(k) clearance?

PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) received FDA 510(k) clearance on 2008-09-12, under 510(k) number K082312.

Who is the listed applicant for PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)?

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

What is the FDA product code for PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)?

The FDA product code for PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) is DPS.

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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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