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FDA 510(k)

RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE

K-Number: K850365 · 1985-04-09

ApplicantEaton Medical Group
Decision Date1985-04-09
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE 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 1985-04-09 under 510(k) number K850365. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE?

RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Eaton Medical Group. The 510(k) number is K850365.

When did RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE receive FDA 510(k) clearance?

RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE received FDA 510(k) clearance on 1985-04-09, under 510(k) number K850365.

Who is the listed applicant for RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE?

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 RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE?

The FDA product code for RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE is DSF.

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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: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, Inc.

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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