FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

FUKUDA DENSHI USA, INC.

The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Dynascope Model Ds-8100n/8100m Patient Monitor.

Pre-market Notification Details

• Device ID: K134046
• 510k Number: K134046
• Device Name: FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911
• Contact: Doug Blakely
• Correspondent: Doug Blakely; FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-31
• Decision Date: 2015-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04538612910326	K134046	000
04538612910333	K134046	000
04538612910074	K134046	000
04538612909382	K134046	000
04538612054167	K134046	000
04538612911002	K134046	000
04538612916212	K134046	000
04538612916205	K134046	000
04538612916199	K134046	000
04538612916182	K134046	000
04538612916175	K134046	000
04538612916168	K134046	000
04538612916151	K134046	000
04538612916144	K134046	000
04538612916137	K134046	000
04538612910357	K134046	000
04538612910470	K134046	000
04538612910302	K134046	000
04538612909962	K134046	000
04538612910852	K134046	000
04538612910821	K134046	000
04538612910814	K134046	000
04538612910807	K134046	000
04538612910791	K134046	000
04538612909955	K134046	000
04538612227561	K134046	000
04538612017100	K134046	000
04538612911200	K134046	000
04538612910968	K134046	000
04538612910494	K134046	000
04538612910487	K134046	000
04538612916120	K134046	000