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FDA 510(k)

SCOLE 300 ECG RECORDER

K-Number: K923664 · 1994-01-13

ApplicantScole Engineering Co.
Decision Date1994-01-13
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCOLE 300 ECG RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Scole Engineering Co.. It received FDA 510(k) clearance on 1994-01-13 under 510(k) number K923664. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOLE 300 ECG RECORDER?

SCOLE 300 ECG RECORDER is a medical device that received FDA 510(k) clearance on 1994-01-13. The listed applicant is Scole Engineering Co.. The 510(k) number is K923664.

When did SCOLE 300 ECG RECORDER receive FDA 510(k) clearance?

SCOLE 300 ECG RECORDER received FDA 510(k) clearance on 1994-01-13, under 510(k) number K923664.

Who is the listed applicant for SCOLE 300 ECG RECORDER?

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

What is the FDA product code for SCOLE 300 ECG RECORDER?

The FDA product code for SCOLE 300 ECG RECORDER is DSH.

Related Clinical Trials

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.

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Other records listing Scole Engineering Co. 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.

K822362ALTA II ECG RECORDERK822363ALTA III ECG RECORDERK770829RECORDING UNIT, MODEL 1445

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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