The following data is part of a premarket notification filed by Ml Strategies, Inc. with the FDA for Framewave Web.
| Device ID | K983401 |
| 510k Number | K983401 |
| Device Name: | FRAMEWAVE WEB |
| Classification | System, Image Processing, Radiological |
| Applicant | ML STRATEGIES, INC. ONE FINANCIAL CENTER BOSTON, MA 02111 |
| Contact | ALLAN M GREEN |
| Correspondent | ALLAN M GREEN ML STRATEGIES, INC. ONE FINANCIAL CENTER BOSTON, MA 02111 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-28 |
| Decision Date | 1998-12-15 |