MedWand

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

MedWand Solutions, Inc.

The following data is part of a premarket notification filed by Medwand Solutions, Inc. with the FDA for Medwand.

Pre-market Notification Details

• Device ID: K212975
• 510k Number: K212975
• Device Name: MedWand
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: MedWand Solutions, Inc. 23162 Arroyo Vista Rancho Santa Margarita, CA 92688
• Contact: Robert Rose
• Correspondent: Natalie J Kennel; NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129
• Product Code: MWI
• Subsequent Product Code: DQA
• Subsequent Product Code: DQD
• Subsequent Product Code: FLL
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-17
• Decision Date: 2022-07-22