The following data is part of a premarket notification filed by Physio Systems, Inc. with the FDA for Discipline Ii Rtd.
Device ID | K871557 |
510k Number | K871557 |
Device Name: | DISCIPLINE II RTD |
Classification | System, Isokinetic Testing And Evaluation |
Applicant | PHYSIO SYSTEMS, INC. 4450 ENTERPRISE ST. STE 101 Fremont, CA 94538 |
Contact | David E Lieberman |
Correspondent | David E Lieberman PHYSIO SYSTEMS, INC. 4450 ENTERPRISE ST. STE 101 Fremont, CA 94538 |
Product Code | IKK |
CFR Regulation Number | 890.1925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-22 |
Decision Date | 1987-08-26 |