The following data is part of a premarket notification filed by Innerspace, Inc with the FDA for Hummingbird Subdural H900ds (drainage And Icp), Hummingbird Subdural- H800s (icp Only).
| Device ID | K113088 |
| 510k Number | K113088 |
| Device Name: | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INNERSPACE, INC 1622 EDINGER AVE STE C Tustin, CA 92780 |
| Contact | Don Bobo |
| Correspondent | Don Bobo INNERSPACE, INC 1622 EDINGER AVE STE C Tustin, CA 92780 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2012-05-02 |
| Summary: | summary |