The following data is part of a premarket notification filed by Ascom (us), Inc. with the FDA for Ascom Clinicalconnex Cardiomax.
| Device ID | K103634 |
| 510k Number | K103634 |
| Device Name: | ASCOM CLINICALCONNEX CARDIOMAX |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | ASCOM (US), INC. PO BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke ASCOM (US), INC. PO BOX 3018 Nederland, CO 80466 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350088670016 | K103634 | 000 |