The following data is part of a premarket notification filed by Howtek, Inc. with the FDA for Howtek 960.
| Device ID | K970908 |
| 510k Number | K970908 |
| Device Name: | HOWTEK 960 |
| Classification | Digitizer, Image, Radiological |
| Applicant | HOWTEK, INC. 21 PARK AVE. Hudson, NH 03051 |
| Contact | M. Russell Leonard |
| Correspondent | M. Russell Leonard HOWTEK, INC. 21 PARK AVE. Hudson, NH 03051 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-11 |
| Decision Date | 1997-05-20 |
| Summary: | summary |