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FDA 510(k)

EK10 ELECTROCARDIOGRAPH

K-Number: K870880 · 1987-04-09

ApplicantBurdick Corp.
Decision Date1987-04-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EK10 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1987-04-09 under 510(k) number K870880. 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 EK10 ELECTROCARDIOGRAPH?

EK10 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1987-04-09. The listed applicant is Burdick Corp.. The 510(k) number is K870880.

When did EK10 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

EK10 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1987-04-09, under 510(k) number K870880.

Who is the listed applicant for EK10 ELECTROCARDIOGRAPH?

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

What is the FDA product code for EK10 ELECTROCARDIOGRAPH?

The FDA product code for EK10 ELECTROCARDIOGRAPH is DPS.

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Other records listing Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK904032ELITE II ELECTROCARDIOGRAPHK903565E560 ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

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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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