The following data is part of a premarket notification filed by Baltimore Therapeutic Equipment Co. with the FDA for The Bte Vector; Analysis System For The Low Back.
Device ID | K925225 |
510k Number | K925225 |
Device Name: | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK |
Classification | Goniometer, Ac-powered |
Applicant | BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
Contact | Kent Fife |
Correspondent | Kent Fife BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
Product Code | KQX |
CFR Regulation Number | 888.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-16 |
Decision Date | 1994-06-27 |