The following data is part of a premarket notification filed by Adaptive Switch Laboratories, Inc. with the FDA for Asl Model #103.
Device ID | K914740 |
510k Number | K914740 |
Device Name: | ASL MODEL #103 |
Classification | Wheelchair, Powered |
Applicant | ADAPTIVE SWITCH LABORATORIES, INC. 1181 BRITTMORE, STE. 500 Houston, TX 77043 |
Contact | James A Swift |
Correspondent | James A Swift ADAPTIVE SWITCH LABORATORIES, INC. 1181 BRITTMORE, STE. 500 Houston, TX 77043 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-21 |
Decision Date | 1991-12-16 |