The following data is part of a premarket notification filed by Defibtech, Llc with the FDA for Rmu-1000 Automated Chest Compression System.
| Device ID | K141809 |
| 510k Number | K141809 |
| Device Name: | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM |
| Classification | Compressor, Cardiac, External |
| Applicant | DEFIBTECH, LLC 741 BOSTON POST ROAD Guilford, CT 06437 |
| Contact | Ed Horton |
| Correspondent | Ed Horton DEFIBTECH, LLC 741 BOSTON POST ROAD Guilford, CT 06437 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815098020690 | K141809 | 000 |
| 00815098020546 | K141809 | 000 |
| 00815098020553 | K141809 | 000 |
| 00815098020560 | K141809 | 000 |
| 00815098020577 | K141809 | 000 |
| 00815098020584 | K141809 | 000 |
| 00815098020621 | K141809 | 000 |
| 00815098020645 | K141809 | 000 |
| 20815098020687 | K141809 | 000 |
| 00815098020539 | K141809 | 000 |