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FDA 510(k)

LP-PLUS

K-Number: K903774 · 1991-08-29

ApplicantFidelity Medical, Inc.
Decision Date1991-08-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LP-PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Fidelity Medical, Inc.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K903774. 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 LP-PLUS?

LP-PLUS is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Fidelity Medical, Inc.. The 510(k) number is K903774.

When did LP-PLUS receive FDA 510(k) clearance?

LP-PLUS received FDA 510(k) clearance on 1991-08-29, under 510(k) number K903774.

Who is the listed applicant for LP-PLUS?

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

What is the FDA product code for LP-PLUS?

The FDA product code for LP-PLUS is DPS.

Other records listing Fidelity Medical, 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.

K983088INSTACINE D-2000K942558INSTACINEK942504INSTASPOTK941917FLUOROPLUA CARDIAC AND/OR INSTAVIEWK872928LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPHK864614LP-3 ELECTROCARDIOGRAPH

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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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