The following data is part of a premarket notification filed by Quantec Image Processing Ltd. with the FDA for Quantec Spinal Measuement System.
Device ID | K923792 |
510k Number | K923792 |
Device Name: | QUANTEC SPINAL MEASUEMENT SYSTEM |
Classification | Device, Sensing, Optical Contour |
Applicant | QUANTEC IMAGE PROCESSING LTD. 37 KING RD. Madison, NJ 07940 |
Contact | Bruce D Groves |
Correspondent | Bruce D Groves QUANTEC IMAGE PROCESSING LTD. 37 KING RD. Madison, NJ 07940 |
Product Code | LDK |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-28 |
Decision Date | 1994-04-20 |