The following data is part of a premarket notification filed by Parker Treadmill Co., Inc. with the FDA for Parker Model Pm.
Device ID | K950376 |
510k Number | K950376 |
Device Name: | PARKER MODEL PM |
Classification | Treadmill, Powered |
Applicant | PARKER TREADMILL CO., INC. 368 INDUSTRY DR. Auburn, AL 36830 |
Contact | Robert Parker |
Correspondent | Robert Parker PARKER TREADMILL CO., INC. 368 INDUSTRY DR. Auburn, AL 36830 |
Product Code | IOL |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-31 |
Decision Date | 1995-09-06 |