The following data is part of a premarket notification filed by Cybex with the FDA for Metabolic Systems.
Device ID | K894154 |
510k Number | K894154 |
Device Name: | METABOLIC SYSTEMS |
Classification | Exerciser, Measuring |
Applicant | CYBEX 2100 SMITHTOWN AVE. P.O. BOX 9003 Ronkonkoma, NY 11779 |
Contact | William Sauer |
Correspondent | William Sauer CYBEX 2100 SMITHTOWN AVE. P.O. BOX 9003 Ronkonkoma, NY 11779 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-14 |
Decision Date | 1989-10-24 |