The following data is part of a premarket notification filed by Baltimore Therapeutic Equipment Co. with the FDA for The Bte Dynamic Lift.
Device ID | K924414 |
510k Number | K924414 |
Device Name: | THE BTE DYNAMIC LIFT |
Classification | System, Isokinetic Testing And Evaluation |
Applicant | BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
Contact | Carl R Lundblad |
Correspondent | Carl R Lundblad BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
Product Code | IKK |
CFR Regulation Number | 890.1925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-31 |
Decision Date | 1993-02-12 |