THUMPER

Compressor, Cardiac, External

MICHIGAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Michigan Instruments, Inc. with the FDA for Thumper.

Pre-market Notification Details

• Device ID: K972525
• 510k Number: K972525
• Device Name: THUMPER
• Classification: Compressor, Cardiac, External
• Applicant: MICHIGAN INSTRUMENTS, INC. 4717 TALON CT., S.E. Grand Rapids, MI 49512
• Contact: James D Maatman
• Correspondent: James D Maatman; MICHIGAN INSTRUMENTS, INC. 4717 TALON CT., S.E. Grand Rapids, MI 49512
• Product Code: DRM
• CFR Regulation Number: 870.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-07
• Decision Date: 1997-10-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860682000107	K972525	000