The following data is part of a premarket notification filed by Shape Medical Systems, Inc with the FDA for Shape-hf Cardiopulmonary Exercise Testing System.
| Device ID | K090722 |
| 510k Number | K090722 |
| Device Name: | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | SHAPE MEDICAL SYSTEMS, INC 1313 5TH AVE. SE SUITE 205 Minneapolis, MN 55414 |
| Contact | Clarence Johnson |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-19 |
| Decision Date | 2009-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B200HF001 | K090722 | 000 |
| B20089001 | K090722 | 000 |
| B20044001 | K090722 | 000 |
| B20040011 | K090722 | 000 |