VITASCORE

Ventilatory Effort Recorder

VITASCORE B.V.

The following data is part of a premarket notification filed by Vitascore B.v. with the FDA for Vitascore.

Pre-market Notification Details

• Device ID: K072014
• 510k Number: K072014
• Device Name: VITASCORE
• Classification: Ventilatory Effort Recorder
• Applicant: VITASCORE B.V. KROMSTRAAT 3 Gemert, NL Nl 5421 Xz
• Contact: Wim Martens
• Correspondent: Wim Martens; VITASCORE B.V. KROMSTRAAT 3 Gemert, NL Nl 5421 Xz
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-23
• Decision Date: 2007-11-08
• Summary: summary