The following data is part of a premarket notification filed by Physio Systems, Inc. with the FDA for Discipline I.
Device ID | K870872 |
510k Number | K870872 |
Device Name: | DISCIPLINE I |
Classification | Exerciser, Measuring |
Applicant | PHYSIO SYSTEMS, INC. 4450 ENTERPRISE ST. STE 101 Fremont, CA 94538 |
Contact | Andrew A Wade |
Correspondent | Andrew A Wade PHYSIO SYSTEMS, INC. 4450 ENTERPRISE ST. STE 101 Fremont, CA 94538 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1987-03-23 |