The following data is part of a premarket notification filed by Semler Technologies, Inc. with the FDA for Compressar Femoral Access Compression Device.
| Device ID | K002767 |
| 510k Number | K002767 |
| Device Name: | COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE |
| Classification | Clamp, Vascular |
| Applicant | SEMLER TECHNOLOGIES, INC. 501 S.E. COLUMBIA SHORES BLVD. SUITE 100 Vancouver, WA 98661 -8064 |
| Contact | Herbert J Semler |
| Correspondent | Herbert J Semler SEMLER TECHNOLOGIES, INC. 501 S.E. COLUMBIA SHORES BLVD. SUITE 100 Vancouver, WA 98661 -8064 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020224 | K002767 | 000 |