The following data is part of a premarket notification filed by Shape Medical Systems, Inc with the FDA for Shape-hf Cardiopulmonary Testing System.
| Device ID | K150888 |
| 510k Number | K150888 |
| Device Name: | Shape-HF Cardiopulmonary Testing System |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | SHAPE MEDICAL SYSTEMS, INC 5000 TOWNSHIP PARKWAY Minneapolis, MN 55110 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath HORWATH RESOURCE GROUP 4486 TIMBERLINE CT. St. Paul, MN 55127 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2016-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B200HF012 | K150888 | 000 |
| B20083012 | K150888 | 000 |
| B20044012 | K150888 | 000 |
| B2009012 | K150888 | 000 |