The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Scout Pro.
Device ID | K033320 |
510k Number | K033320 |
Device Name: | SCOUT PRO |
Classification | Catheter, Percutaneous |
Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
Contact | Jon Brumbaugh |
Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-15 |
Decision Date | 2003-11-19 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SCOUT PRO 76456933 2815636 Live/Registered |
Ohaus Corporation 2002-10-09 |