FDA 510(k)

THUMPER, MODEL: 1008

K-Number: K073079 · 2008-02-14

Decision Date2008-02-14

Product CodeDRM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

THUMPER, MODEL: 1008 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 2008-02-14 under 510(k) number K073079. 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, MODEL: 1008?

THUMPER, MODEL: 1008 is a medical device that received FDA 510(k) clearance on 2008-02-14. The listed applicant is Michigan Instruments, Inc.. The 510(k) number is K073079.

When did THUMPER, MODEL: 1008 receive FDA 510(k) clearance?

THUMPER, MODEL: 1008 received FDA 510(k) clearance on 2008-02-14, under 510(k) number K073079.

Who is the listed applicant for THUMPER, MODEL: 1008?

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, MODEL: 1008?

The FDA product code for THUMPER, MODEL: 1008 is DRM.

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Other records listing Michigan Instruments, Inc. as applicant

K972525THUMPER K962237THUMPER CARDIOPULMONARY RESUSCITATOR K895954LARYNGOSTAT LARYNGOSCOPE HANDLE K851139THUMPER CARDIOPULMONARY RESUSCITATOR 1005 K833879CARDIOPULMONARY RESUSCITATOR K811909CARDIOPULMUNARY RESUSCITATOR

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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.