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 |