The following data is part of a premarket notification filed by Invacare Respiratory Corp. with the FDA for Cat Scooter With Ds60 Vonytollrt.
Device ID | K962583 |
510k Number | K962583 |
Device Name: | CAT SCOOTER WITH DS60 VONYTOLLRT |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | INVACARE RESPIRATORY CORP. 899 CLEVELAND ST. Elyria, OH 44036 -2125 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll INVACARE RESPIRATORY CORP. 899 CLEVELAND ST. Elyria, OH 44036 -2125 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-01 |
Decision Date | 1996-12-18 |
Summary: | summary |