The following data is part of a premarket notification filed by Sense Technology, Inc. with the FDA for Sense Technology Inc. Fras, Sense Technology Inc. Pulstar.
| Device ID | K973914 |
| 510k Number | K973914 |
| Device Name: | SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | SENSE TECHNOLOGY, INC. 3251 OLD FRANKSTOWN RD. Pittsburgh, PA 15239 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1998-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855341008003 | K973914 | 000 |