The following data is part of a premarket notification filed by Innerspace, Inc. with the FDA for Mps Oxiport And Mps Oxiport Plus.
Device ID | K072379 |
510k Number | K072379 |
Device Name: | MPS OXIPORT AND MPS OXIPORT PLUS |
Classification | Device, Monitoring, Intracranial Pressure |
Applicant | INNERSPACE, INC. 1622 EDINGER AVENUE, SUITE C Tustin, CA 92780 |
Contact | Don Bobo |
Correspondent | Don Bobo INNERSPACE, INC. 1622 EDINGER AVENUE, SUITE C Tustin, CA 92780 |
Product Code | GWM |
CFR Regulation Number | 882.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-24 |
Decision Date | 2008-04-29 |
Summary: | summary |