Capsule Vitals Plus Patient Monitoring System

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Capsule Technologie SAS

The following data is part of a premarket notification filed by Capsule Technologie Sas with the FDA for Capsule Vitals Plus Patient Monitoring System.

Pre-market Notification Details

• Device ID: K210204
• 510k Number: K210204
• Device Name: Capsule Vitals Plus Patient Monitoring System
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: Capsule Technologie SAS 76 - 78 Avenue De France Paris, FR 75013
• Contact: Peter Kelley
• Correspondent: Peter Kelley; Capsule Technologie SAS 76 - 78 Avenue De France Paris, FR 75013
• Product Code: MWI
• Subsequent Product Code: CCK
• Subsequent Product Code: DQA
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-01-26
• Decision Date: 2021-10-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03615040001640	K210204	000
03615040001800	K210204	000
03615040001817	K210204	000
03615040001824	K210204	000
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03615040002319	K210204	000
03615040002326	K210204	000
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03615040001954	K210204	000
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03615040002449	K210204	000