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FDA 510(k)

EK-670

K-Number: K780138 · 1978-02-17

ApplicantBurdick Corp.
Decision Date1978-02-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EK-670 is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1978-02-17 under 510(k) number K780138. 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 EK-670?

EK-670 is a medical device that received FDA 510(k) clearance on 1978-02-17. The listed applicant is Burdick Corp.. The 510(k) number is K780138.

When did EK-670 receive FDA 510(k) clearance?

EK-670 received FDA 510(k) clearance on 1978-02-17, under 510(k) number K780138.

Who is the listed applicant for EK-670?

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 EK-670?

The FDA product code for EK-670 is DPS.

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

View all 38 devices →

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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