The following data is part of a premarket notification filed by Technology For Imaging, Inc. with the FDA for Endoscopic Light Source.
| Device ID | K885183 |
| 510k Number | K885183 |
| Device Name: | ENDOSCOPIC LIGHT SOURCE |
| Classification | Arthroscope |
| Applicant | TECHNOLOGY FOR IMAGING, INC. 200 HOMER AVE. Ashland, MA 01721 |
| Contact | Richard Schermerhorn |
| Correspondent | Richard Schermerhorn TECHNOLOGY FOR IMAGING, INC. 200 HOMER AVE. Ashland, MA 01721 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-13 |
| Decision Date | 1989-03-09 |