The following data is part of a premarket notification filed by Advanced Circulatory System, A Wholly Owned Subsidiary Of with the FDA for Vpod Itpr.
| Device ID | K172388 |
| 510k Number | K172388 |
| Device Name: | VPOD ITPR |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Advanced Circulatory System, A Wholly Owned Subsidiary Of ZOLL 1905 County Rd C West Roseville, MN 55113 |
| Contact | Anja Metzger |
| Correspondent | Paul E. Dryden Advanced Circulatory System, A Wholly Owned Subsidiary Of ZOLL C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-08 |
| Decision Date | 2017-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946028343 | K172388 | 000 |
| 00847946028336 | K172388 | 000 |
| 00847946028350 | K172388 | 000 |