The following data is part of a premarket notification filed by Michigan Instruments, Inc. with the FDA for Thumper Cardiopulmonary Resuscitator 1005.
Device ID | K851139 |
510k Number | K851139 |
Device Name: | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 |
Classification | Compressor, Cardiac, External |
Applicant | MICHIGAN INSTRUMENTS, INC. 4717 TALON CT., S.E. Grand Rapids, MI 49512 |
Contact | Jim Maatman |
Correspondent | Jim 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 | 1985-03-21 |
Decision Date | 1985-05-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860682000114 | K851139 | 000 |
00860682000107 | K851139 | 000 |