The following data is part of a premarket notification filed by Advanced Circulatory Systems, Inc. with the FDA for Lifestyle Circulatory Enhancer.
| Device ID | K040084 |
| 510k Number | K040084 |
| Device Name: | LIFESTYLE CIRCULATORY ENHANCER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | ADVANCED CIRCULATORY SYSTEMS, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring ADVANCED CIRCULATORY SYSTEMS, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | BWF |
| Subsequent Product Code | DWL |
| Subsequent Product Code | JOW |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-15 |
| Decision Date | 2004-04-07 |
| Summary: | summary |