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FDA 510(k)

QEKG ELECTROCARDIOGRAPH

K-Number: K897121 · 1990-04-30

ApplicantQmed, Inc.
Decision Date1990-04-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QEKG ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Qmed, Inc.. It received FDA 510(k) clearance on 1990-04-30 under 510(k) number K897121. 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 QEKG ELECTROCARDIOGRAPH?

QEKG ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1990-04-30. The listed applicant is Qmed, Inc.. The 510(k) number is K897121.

When did QEKG ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

QEKG ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1990-04-30, under 510(k) number K897121.

Who is the listed applicant for QEKG ELECTROCARDIOGRAPH?

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

What is the FDA product code for QEKG ELECTROCARDIOGRAPH?

The FDA product code for QEKG ELECTROCARDIOGRAPH is DPS.

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Other records listing Qmed, 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.

K972991MONITOR ONE NDXK932109PROFILOMATK921476INTERP-1000K873591A.R.M. (ASPEN RETURN MONITOR)K862377QMED SELF ADHERING ELECTRODEK863091BICORD BY QMED

View all 11 devices →

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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