VISENSIA

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

OBS MEDICAL

The following data is part of a premarket notification filed by Obs Medical with the FDA for Visensia.

Pre-market Notification Details

• Device ID: K081140
• 510k Number: K081140
• Device Name: VISENSIA
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: OBS MEDICAL 11495 PENNSYLVANIA ST. STE. 250 Carmel, IN 46032
• Contact: Wayne Nethercutt
• Correspondent: Wayne Nethercutt; OBS MEDICAL 11495 PENNSYLVANIA ST. STE. 250 Carmel, IN 46032
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-22
• Decision Date: 2008-07-17
• Summary: summary