The following data is part of a premarket notification filed by Resuscitation International with the FDA for Miniaturize Chest Compressor (mcc).
| Device ID | K102068 |
| 510k Number | K102068 |
| Device Name: | MINIATURIZE CHEST COMPRESSOR (MCC) |
| Classification | Compressor, Cardiac, External |
| Applicant | RESUSCITATION INTERNATIONAL 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Robyn Scopis |
| Correspondent | Robyn Scopis RESUSCITATION INTERNATIONAL 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-23 |
| Decision Date | 2010-11-16 |
| Summary: | summary |