The following data is part of a premarket notification filed by Ics Medical Corp. with the FDA for Rvt-50 Rotary Chair For Vestibular Testing.
Device ID | K872093 |
510k Number | K872093 |
Device Name: | RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING |
Classification | Apparatus, Vestibular Analysis |
Applicant | ICS MEDICAL CORP. 2227 HAMMOND DR. Schaumburg, IL 60173 -3860 |
Contact | Delmar F Bloem |
Correspondent | Delmar F Bloem ICS MEDICAL CORP. 2227 HAMMOND DR. Schaumburg, IL 60173 -3860 |
Product Code | LXV |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-01 |
Decision Date | 1987-09-16 |