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FDA 510(k)

EASI 12 LEAD ALGORITHM

K-Number: K020456 · 2002-07-09

ApplicantPhilips Medical Systems
Decision Date2002-07-09
Product CodeDRW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EASI 12 LEAD ALGORITHM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2002-07-09 under 510(k) number K020456. The device is classified under product code DRW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASI 12 LEAD ALGORITHM?

EASI 12 LEAD ALGORITHM is a medical device that received FDA 510(k) clearance on 2002-07-09. The listed applicant is Philips Medical Systems. The 510(k) number is K020456.

When did EASI 12 LEAD ALGORITHM receive FDA 510(k) clearance?

EASI 12 LEAD ALGORITHM received FDA 510(k) clearance on 2002-07-09, under 510(k) number K020456.

Who is the listed applicant for EASI 12 LEAD ALGORITHM?

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

What is the FDA product code for EASI 12 LEAD ALGORITHM?

The FDA product code for EASI 12 LEAD ALGORITHM is DRW.

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Other records listing Philips Medical Systems as applicant

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Related Devices (Code: DRW)

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.

K033513EASI ECG ALGORITHMPhilips Medical SystemsK930786EPCORSiemens Medical Solutions USA, Inc.K872781EASI LEAD SYSTEM CABLE ASSEMBLYTotemite Medical ElectronicsK861981ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTORVital Signs, Inc.K851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTREaton Medical GroupK851632PCX-100 PATIENT INPUT LEADWIREEaton Medical Group

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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