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FDA 510(k)

ISOLATED ELECTROCARDIOGRAPH MODEL 1207

K-Number: K770366 · 1977-03-01

ApplicantElectronics For Medicine, Inc.
Decision Date1977-03-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ISOLATED ELECTROCARDIOGRAPH MODEL 1207 is the device name listed in this FDA 510(k) record. The listed applicant is Electronics For Medicine, Inc.. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K770366. 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 ISOLATED ELECTROCARDIOGRAPH MODEL 1207?

ISOLATED ELECTROCARDIOGRAPH MODEL 1207 is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is Electronics For Medicine, Inc.. The 510(k) number is K770366.

When did ISOLATED ELECTROCARDIOGRAPH MODEL 1207 receive FDA 510(k) clearance?

ISOLATED ELECTROCARDIOGRAPH MODEL 1207 received FDA 510(k) clearance on 1977-03-01, under 510(k) number K770366.

Who is the listed applicant for ISOLATED ELECTROCARDIOGRAPH MODEL 1207?

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

What is the FDA product code for ISOLATED ELECTROCARDIOGRAPH MODEL 1207?

The FDA product code for ISOLATED ELECTROCARDIOGRAPH MODEL 1207 is DPS.

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Other records listing Electronics For Medicine, 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.

K830791UNIVERSAL MEDDARS SYSTEMK830795CABINET FOR MULTIPLE FUNCTION BLOCKSK792528RESPIRATION/APNEA AMPLIFIER MODEL 3105K791006SMART BILECTRODESK790198MONITOR PLUG-IN MODEL M1106 ECGK790203INTERVAL TIMER MODEL V4295

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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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