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FDA 510(k)

HOLTER ECG SCANNER

K-Number: K820014 · 1982-04-21

ApplicantLaser Scan Corp.
Decision Date1982-04-21
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER ECG SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Laser Scan Corp.. It received FDA 510(k) clearance on 1982-04-21 under 510(k) number K820014. 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 HOLTER ECG SCANNER?

HOLTER ECG SCANNER is a medical device that received FDA 510(k) clearance on 1982-04-21. The listed applicant is Laser Scan Corp.. The 510(k) number is K820014.

When did HOLTER ECG SCANNER receive FDA 510(k) clearance?

HOLTER ECG SCANNER received FDA 510(k) clearance on 1982-04-21, under 510(k) number K820014.

Who is the listed applicant for HOLTER ECG SCANNER?

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

What is the FDA product code for HOLTER ECG SCANNER?

The FDA product code for HOLTER ECG SCANNER is DPS.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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