The following data is part of a premarket notification filed by Semler Technologies, Inc. Dba with the FDA for Compass Compression Assist Handle.
| Device ID | K053398 |
| 510k Number | K053398 |
| Device Name: | COMPASS COMPRESSION ASSIST HANDLE |
| Classification | Clamp, Vascular |
| Applicant | SEMLER TECHNOLOGIES, INC. DBA 2326 NW EVERETT ST. Portland, OR 97027 |
| Contact | Herbert J Semler |
| Correspondent | Herbert J Semler SEMLER TECHNOLOGIES, INC. DBA 2326 NW EVERETT ST. Portland, OR 97027 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-06 |
| Decision Date | 2006-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020002 | K053398 | 000 |