The following data is part of a premarket notification filed by Bruno Independent Living Aids, Inc. with the FDA for Bruno Electra-ride Stair-way Elevator System.
Device ID | K921648 |
510k Number | K921648 |
Device Name: | BRUNO ELECTRA-RIDE STAIR-WAY ELEVATOR SYSTEM |
Classification | Transport, Patient, Powered |
Applicant | BRUNO INDEPENDENT LIVING AIDS, INC. 430 ARMOUR COURT Oconomowoc, WI 53066 |
Contact | Belson Iii |
Correspondent | Belson Iii BRUNO INDEPENDENT LIVING AIDS, INC. 430 ARMOUR COURT Oconomowoc, WI 53066 |
Product Code | ILK |
CFR Regulation Number | 890.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-06 |
Decision Date | 1992-05-04 |