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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K982255
Device Name MODEL 2000 PULSE OXIMETER
Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact DICK LISTRO
Correspondent
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact DICK LISTRO
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/26/1998
Decision Date 10/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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