The following data is part of a premarket notification filed by J-tech, Inc. with the FDA for Inclinometer.
Device ID | K954647 |
510k Number | K954647 |
Device Name: | INCLINOMETER |
Classification | Goniometer, Ac-powered |
Applicant | J-TECH, INC. 50 WEST CANYON RD. Alpine, UT 84004 |
Contact | J. Tracy Livingston |
Correspondent | J. Tracy Livingston J-TECH, INC. 50 WEST CANYON RD. Alpine, UT 84004 |
Product Code | KQX |
CFR Regulation Number | 888.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-10 |
Decision Date | 1995-10-30 |