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FDA 510(k)

PRIME ECG SYSTEM

K-Number: K012414 · 2002-03-06

ApplicantMeridian Medical Technologies, Inc.
Decision Date2002-03-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRIME ECG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Medical Technologies, Inc.. It received FDA 510(k) clearance on 2002-03-06 under 510(k) number K012414. 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?

PRIME ECG SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-06. The listed applicant is Meridian Medical Technologies, Inc.. The 510(k) number is K012414.

When did PRIME ECG SYSTEM receive FDA 510(k) clearance?

PRIME ECG SYSTEM received FDA 510(k) clearance on 2002-03-06, under 510(k) number K012414.

Who is the listed applicant for PRIME ECG SYSTEM?

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

What is the FDA product code for PRIME ECG SYSTEM?

The FDA product code for PRIME ECG SYSTEM 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 Meridian Medical 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.

K030104PRIME ECG SYSTEMK965101CARDIOBEEPER CB-12L

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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