Atlas FDA

BRUNO ELAN STAIRWAY ELEVATOR

FDA 510(k) clearance K113308 · decided 2012-02-01

Clearance details

K-number
K113308
Device name
BRUNO ELAN STAIRWAY ELEVATOR
Applicant
Bruno Independent Living Aids, Inc.
Decision
Substantially Equivalent
Date received
2011-11-09
Decision date
2012-02-01
Days to decision
84 days
Clearance type
Special
Product code
ILK
Device class
2
Regulation number
890.5150
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Oconomowoc, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.