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FDA 510(k)

MONITOR ONE NDX

K-Number: K972991 · 1998-12-03

ApplicantQmed, Inc.
Decision Date1998-12-03
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR ONE NDX is the device name listed in this FDA 510(k) record. The listed applicant is Qmed, Inc.. It received FDA 510(k) clearance on 1998-12-03 under 510(k) number K972991. 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 MONITOR ONE NDX?

MONITOR ONE NDX is a medical device that received FDA 510(k) clearance on 1998-12-03. The listed applicant is Qmed, Inc.. The 510(k) number is K972991.

When did MONITOR ONE NDX receive FDA 510(k) clearance?

MONITOR ONE NDX received FDA 510(k) clearance on 1998-12-03, under 510(k) number K972991.

Who is the listed applicant for MONITOR ONE NDX?

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 MONITOR ONE NDX?

The FDA product code for MONITOR ONE NDX 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.

K932109PROFILOMATK921476INTERP-1000K897121QEKG ELECTROCARDIOGRAPHK873591A.R.M. (ASPEN RETURN MONITOR)K862377QMED SELF ADHERING ELECTRODEK863091BICORD BY QMED

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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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