The following data is part of a premarket notification filed by Advanced Circulatory Systems, Inc. with the FDA for Cirqlator Intrathoracic Pressure Regulator (itpr).
| Device ID | K070490 |
| 510k Number | K070490 |
| Device Name: | CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | ADVANCED CIRCULATORY SYSTEMS, INC. 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ADVANCED CIRCULATORY SYSTEMS, INC. 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-06-20 |
| Summary: | summary |