Ascent Cardiorespiratory Diagnostic Software
Calculator, Predicted Values, Pulmonary Function
Medical Graphics Corporation
The following data is part of a premarket notification filed by Medical Graphics Corporation with the FDA for Ascent Cardiorespiratory Diagnostic Software.
Pre-market Notification Details
| Device ID | K181912 |
| 510k Number | K181912 |
| Device Name: | Ascent Cardiorespiratory Diagnostic Software |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | Medical Graphics Corporation 350 Oak Grove Parkway Saint Paul, MN 55127 -8599 |
| Contact | Jim Mcgurran |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-07-17 |
| Decision Date | 2019-04-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810016250579 | K181912 | 000 |
| 00810016250555 | K181912 | 000 |
Trademark Results [Ascent Cardiorespiratory Diagnostic Software]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASCENT CARDIORESPIRATORY DIAGNOSTIC SOFTWARE 87827334 not registered Dead/Abandoned |
MGC Diagnostics Corporation 2018-03-09 |
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