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FDA 510(k)

RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH

K-Number: K850322 · 1985-05-16

ApplicantEaton Medical Group
Decision Date1985-05-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Eaton Medical Group. It received FDA 510(k) clearance on 1985-05-16 under 510(k) number K850322. 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 RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH?

RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1985-05-16. The listed applicant is Eaton Medical Group. The 510(k) number is K850322.

When did RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1985-05-16, under 510(k) number K850322.

Who is the listed applicant for RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH?

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

What is the FDA product code for RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH?

The FDA product code for RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH is DPS.

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Other records listing Eaton Medical Group 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.

K851623MODEL TRC-40 TELEMETRY RECIEVER MODULEK851624MODEL TT-185 TELEMETRY TRANSMITTERK851625SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000K851632PCX-100 PATIENT INPUT LEADWIREK851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTRK851631TMX-C1/C2 TRADMILL CONTROLLER ACCESS.

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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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