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FDA 510(k)

EKG 501 A

K-Number: K840569 · 1985-12-30

ApplicantBosch Hearing Instruments, Inc.
Decision Date1985-12-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKG 501 A is the device name listed in this FDA 510(k) record. The listed applicant is Bosch Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1985-12-30 under 510(k) number K840569. 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 EKG 501 A?

EKG 501 A is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Bosch Hearing Instruments, Inc.. The 510(k) number is K840569.

When did EKG 501 A receive FDA 510(k) clearance?

EKG 501 A received FDA 510(k) clearance on 1985-12-30, under 510(k) number K840569.

Who is the listed applicant for EKG 501 A?

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

What is the FDA product code for EKG 501 A?

The FDA product code for EKG 501 A is DPS.

Other records listing Bosch Hearing Instruments, 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.

K840571EKG 503AK840574EBM-500K822579BOSCH STAR 66F-SP HEARING AIDK820041BOSCH TOP STAR IIIK810347BOSCH STAR 66F SUPER EARLEVEL AIDK800779OMNITON MT80-A BODY HEARING AID

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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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