Cleared Traditional

INVALIFT

K910830 · American Invalift Corp. · General Hospital
Jun 1992
Decision
468d
Days
Class 2
Risk

About This 510(k) Submission

K910830 is an FDA 510(k) clearance for the INVALIFT, a Device, Patient Transfer, Powered (Class II — Special Controls, product code FRZ), submitted by American Invalift Corp. (White Plains, US). The FDA issued a Cleared decision on June 9, 1992, 468 days after receiving the submission on February 27, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6775.

Submission Details

510(k) Number K910830 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1991
Decision Date June 09, 1992
Days to Decision 468 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRZ — Device, Patient Transfer, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6775