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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K992387
Device Name ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
Applicant
Rossmax International , Ltd.
2f. # 10, Aly. 20 Ln. 106
Section 3, Nan Kang Rd.
Taipei,  TW
Applicant Contact MICHAEL YEH
Correspondent
Rossmax International , Ltd.
2f. # 10, Aly. 20 Ln. 106
Section 3, Nan Kang Rd.
Taipei,  TW
Correspondent Contact MICHAEL YEH
Regulation Number870.2100
Classification Product Code
DPW  
Date Received07/19/1999
Decision Date 08/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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