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FDA 510(k)

ALTAIR 6100 CASSETTE RECORDER

K-Number: K942438 · 1994-08-05

ApplicantBurdick, Inc.
Decision Date1994-08-05
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALTAIR 6100 CASSETTE RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Burdick, Inc.. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K942438. 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 ALTAIR 6100 CASSETTE RECORDER?

ALTAIR 6100 CASSETTE RECORDER is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Burdick, Inc.. The 510(k) number is K942438.

When did ALTAIR 6100 CASSETTE RECORDER receive FDA 510(k) clearance?

ALTAIR 6100 CASSETTE RECORDER received FDA 510(k) clearance on 1994-08-05, under 510(k) number K942438.

Who is the listed applicant for ALTAIR 6100 CASSETTE RECORDER?

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

What is the FDA product code for ALTAIR 6100 CASSETTE RECORDER?

The FDA product code for ALTAIR 6100 CASSETTE RECORDER is DSH.

Related Clinical Trials

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Other records listing Burdick, 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.

K952417QUEST EXERCISE STRESS SYSTEMK954267BURDICK 200 PULSE OXIMETERK946281ECLIPSE 4 ELECTROCARDIOGRAPHK945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400K943959ECLIPSE 4 ELECTROCARDIOGRAPH

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

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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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