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FDA 510(k)

ECG SIMULATOR MODEL ECGPLUS

K-Number: K893660 · 1989-12-05

ApplicantBio-Tek Instruments, Inc.
Decision Date1989-12-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG SIMULATOR MODEL ECGPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1989-12-05 under 510(k) number K893660. 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 ECG SIMULATOR MODEL ECGPLUS?

ECG SIMULATOR MODEL ECGPLUS is a medical device that received FDA 510(k) clearance on 1989-12-05. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K893660.

When did ECG SIMULATOR MODEL ECGPLUS receive FDA 510(k) clearance?

ECG SIMULATOR MODEL ECGPLUS received FDA 510(k) clearance on 1989-12-05, under 510(k) number K893660.

Who is the listed applicant for ECG SIMULATOR MODEL ECGPLUS?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG SIMULATOR MODEL ECGPLUS?

The FDA product code for ECG SIMULATOR MODEL ECGPLUS is DPS.

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Other records listing Bio-Tek Instruments, Inc. as applicant

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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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