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FDA 510(k)

THUMPER

K-Number: K972525 · 1997-10-02

ApplicantMichigan Instruments, Inc.
Decision Date1997-10-02
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THUMPER is the device name listed in this FDA 510(k) record. The listed applicant is Michigan Instruments, Inc.. It received FDA 510(k) clearance on 1997-10-02 under 510(k) number K972525. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THUMPER?

THUMPER is a medical device that received FDA 510(k) clearance on 1997-10-02. The listed applicant is Michigan Instruments, Inc.. The 510(k) number is K972525.

When did THUMPER receive FDA 510(k) clearance?

THUMPER received FDA 510(k) clearance on 1997-10-02, under 510(k) number K972525.

Who is the listed applicant for THUMPER?

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

What is the FDA product code for THUMPER?

The FDA product code for THUMPER is DRM.

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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 Michigan 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.

K073079THUMPER, MODEL: 1008K962237THUMPER CARDIOPULMONARY RESUSCITATORK895954LARYNGOSTAT LARYNGOSCOPE HANDLEK851139THUMPER CARDIOPULMONARY RESUSCITATOR 1005K833879CARDIOPULMONARY RESUSCITATORK811909CARDIOPULMUNARY RESUSCITATOR

View all 7 devices →

Related Devices (Code: DRM)

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.

K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLCK173553LUCAS 3 Chest Compression SystemJolife ABK161768LUCAS 3 Chest Compression SystemJolife ABK153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLCK112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation

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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