The following data is part of a premarket notification filed by Siemens Burdick, Inc. with the FDA for Ta620 Treadmill Controller.
Device ID | K913518 |
510k Number | K913518 |
Device Name: | TA620 TREADMILL CONTROLLER |
Classification | Treadmill, Powered |
Applicant | SIEMENS BURDICK, INC. 15 PLUMB ST. Miltoon, WI 53563 |
Contact | Paul Appel |
Correspondent | Paul Appel SIEMENS BURDICK, INC. 15 PLUMB ST. Miltoon, WI 53563 |
Product Code | IOL |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-07 |
Decision Date | 1991-10-24 |