The following data is part of a premarket notification filed by Technology For Imaging, Inc. with the FDA for Endoscopic Video Camera.
Device ID | K863800 |
510k Number | K863800 |
Device Name: | ENDOSCOPIC VIDEO CAMERA |
Classification | Camera, Surgical And Accessories |
Applicant | TECHNOLOGY FOR IMAGING, INC. 24 PARKER RD. Framingham, MA 01701 |
Contact | Richard Schermerhorn |
Correspondent | Richard Schermerhorn TECHNOLOGY FOR IMAGING, INC. 24 PARKER RD. Framingham, MA 01701 |
Product Code | KQM |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-29 |
Decision Date | 1986-10-14 |