The following data is part of a premarket notification filed by Medspira, Llc with the FDA for Mcompass Anorectal Manometry System.
| Device ID | K120088 |
| 510k Number | K120088 |
| Device Name: | MCOMPASS ANORECTAL MANOMETRY SYSTEM |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | MEDSPIRA, LLC 2718 SUMMER STREET NE Minneapolis, MN 55413 |
| Contact | Jim Quackenbush |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-01-11 |
| Decision Date | 2012-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851607003058 | K120088 | 000 |
| 00851607003044 | K120088 | 000 |