The following data is part of a premarket notification filed by Howtek, Inc. with the FDA for Digitizer Director (hsc025-01).
| Device ID | K972191 |
| 510k Number | K972191 |
| Device Name: | DIGITIZER DIRECTOR (HSC025-01) |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | HOWTEK, INC. 21 PARK AVE. Hudson, NH 03051 |
| Contact | Russell Leonard |
| Correspondent | Russell Leonard HOWTEK, INC. 21 PARK AVE. Hudson, NH 03051 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-10 |
| Decision Date | 1997-09-08 |
| Summary: | summary |