Cleared Traditional

AMSINO CLINICAL THERMOMETER

K960185 · Amsia Intl., Inc. · General Hospital

Mar 1996

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K960185 is an FDA 510(k) clearance for the AMSINO CLINICAL THERMOMETER, a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK), submitted by Amsia Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on March 28, 1996, 72 days after receiving the submission on January 16, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2920.

Submission Details

510(k) Number	K960185 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1996
Decision Date	March 28, 1996
Days to Decision	72 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement