The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Pulse Guard 3fr Electrode.
| Device ID | K944571 |
| 510k Number | K944571 |
| Device Name: | PULSE GUARD 3FR ELECTRODE |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Casey Kurek |
| Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1995-03-17 |