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FDA 510(k)

ALTA II ECG RECORDER

K-Number: K822362 · 1983-01-14

ApplicantScole Engineering Co.
Decision Date1983-01-14
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALTA II 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 1983-01-14 under 510(k) number K822362. 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 ALTA II ECG RECORDER?

ALTA II ECG RECORDER is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Scole Engineering Co.. The 510(k) number is K822362.

When did ALTA II ECG RECORDER receive FDA 510(k) clearance?

ALTA II ECG RECORDER received FDA 510(k) clearance on 1983-01-14, under 510(k) number K822362.

Who is the listed applicant for ALTA II 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 ALTA II ECG RECORDER?

The FDA product code for ALTA II ECG RECORDER is DSH.

Related Clinical Trials

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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.

K923664SCOLE 300 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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