The following data is part of a premarket notification filed by Garaventa (canada) Ltd. with the FDA for Stair-lift.
Device ID | K981486 |
510k Number | K981486 |
Device Name: | STAIR-LIFT |
Classification | Elevator, Wheelchair, Portable |
Applicant | GARAVENTA (CANADA) LTD. 1225 EYE ST., N.W. SUITE 1150 Washington, DC 20005 |
Contact | Alyssa Chumnanvech |
Correspondent | Alyssa Chumnanvech GARAVENTA (CANADA) LTD. 1225 EYE ST., N.W. SUITE 1150 Washington, DC 20005 |
Product Code | ING |
CFR Regulation Number | 890.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-24 |
Decision Date | 1998-07-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B24004 | K981486 | 000 |
B24003 | K981486 | 000 |