SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM

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

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Ultraview Digital Telemtry System.

Pre-market Notification Details

• Device ID: K983996
• 510k Number: K983996
• Device Name: SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: SPACELABS MEDICAL, INC. 15220 N.E. 40TH ST. Redmond, WA 98073 -9713
• Contact: Nancy J Gertlar
• Correspondent: Nancy J Gertlar; SPACELABS MEDICAL, INC. 15220 N.E. 40TH ST. Redmond, WA 98073 -9713
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-10
• Decision Date: 1999-06-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841522101205	K983996	000
10841522105463	K983996	000
10841522105470	K983996	000
10841522105487	K983996	000
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10841522105586	K983996	000
10841522105616	K983996	000
10841522105623	K983996	000
10841522105630	K983996	000
10841522105456	K983996	000
10841522105425	K983996	000
10841522101274	K983996	000
10841522105203	K983996	000
10841522105258	K983996	000
10841522105265	K983996	000
10841522105296	K983996	000
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10841522105326	K983996	000
10841522105333	K983996	000
10841522105340	K983996	000
10841522105418	K983996	000
10841522105647	K983996	000
10841522105654	K983996	000
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10841522101519	K983996	000
10841522101618	K983996	000
10841522101656	K983996	000
10841522101687	K983996	000
10841522101717	K983996	000
10841522102134	K983996	000
10841522108693	K983996	000
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10841522119224	K983996	000
10841522101397	K983996	000
10841522101328	K983996	000
10841522105869	K983996	000
10841522108402	K983996	000
10841522108426	K983996	000
10841522108464	K983996	000
10841522108631	K983996	000
10841522108648	K983996	000
10841522108662	K983996	000
10841522102271	K983996	000
10841522100680	K983996	000
10841522100734	K983996	000
10841522119385	K983996	000