The following data is part of a premarket notification filed by Advanced Circulatory Systems, Inc. with the FDA for Modification To Resqpod Circulatory Enhancer.
| Device ID | K033401 |
| 510k Number | K033401 |
| Device Name: | MODIFICATION TO RESQPOD 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 |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-24 |
| Decision Date | 2003-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946028329 | K033401 | 000 |
| 00847946028299 | K033401 | 000 |
| 00847946026936 | K033401 | 000 |
| 00847946026929 | K033401 | 000 |
| 00847946026912 | K033401 | 000 |
| 00847946045326 | K033401 | 000 |