Connex Spot Monitor,901058 Vital Signs Monitor Core

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

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Connex Spot Monitor,901058 Vital Signs Monitor Core.

Pre-market Notification Details

• Device ID: K142356
• 510k Number: K142356
• Device Name: Connex Spot Monitor,901058 Vital Signs Monitor Core
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Contact: Kevin Crossen
• Correspondent: Kevin Crossen; WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Product Code: MWI
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-08-25
• Decision Date: 2014-12-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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