Dictum Health

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

Dictum Health, Inc.

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

Pre-market Notification Details

• Device ID: K170798
• 510k Number: K170798
• Device Name: Dictum Health
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: Dictum Health, Inc. 255 3rd Avenue Suite 102 Oakland, CA 94607
• Contact: Paul Landesman
• Correspondent: Daniel Kamm; Kamm & Associates 8870 Ravello Ct Naples, FL 34114
• Product Code: MWI
• Subsequent Product Code: BZG
• Subsequent Product Code: DPS
• Subsequent Product Code: DQA
• Subsequent Product Code: DQD
• Subsequent Product Code: DRX
• Subsequent Product Code: DXN
• Subsequent Product Code: DXQ
• Subsequent Product Code: EWO
• Subsequent Product Code: FLL
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-17
• Decision Date: 2017-07-14
• Summary: summary