The following data is part of a premarket notification filed by Genus Medical, Inc. with the FDA for Cat Scooter.
Device ID | K941966 |
510k Number | K941966 |
Device Name: | CAT SCOOTER |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | GENUS MEDICAL, INC. 441-A APPLEWOOD CRES Concord, Ont, CA |
Contact | Nelson Pang |
Correspondent | Nelson Pang GENUS MEDICAL, INC. 441-A APPLEWOOD CRES Concord, Ont, CA |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-22 |
Decision Date | 1994-05-06 |