The following data is part of a premarket notification filed by Medspira, Llc with the FDA for Mcompass Biofeedback Anorectal Manometry System.
| Device ID | K143031 |
| 510k Number | K143031 |
| Device Name: | Mcompass Biofeedback Anorectal Manometry System |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | MEDSPIRA, LLC 2718 SUMMER STREET NE Minneapolis, MN 55413 |
| Contact | Jim Quackenbush |
| Correspondent | Jim Quackenbush MEDSPIRA, LLC 2718 SUMMER STREET NE Minneapolis, MN 55413 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-21 |
| Decision Date | 2015-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20851607003079 | K143031 | 000 |
| 00851607003334 | K143031 | 000 |
| 10851607003348 | K143031 | 000 |
| 10851607003393 | K143031 | 000 |
| 10851607003317 | K143031 | 000 |
| 00851607003280 | K143031 | 000 |
| 00851607003273 | K143031 | 000 |
| 20851607003185 | K143031 | 000 |
| 10851607003065 | K143031 | 000 |
| 00851607003327 | K143031 | 000 |