SOFTECH Plus ETCO2 Cannula

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

TELEFLEX MEDICAL, INC.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Softech Plus Etco2 Cannula.

Pre-market Notification Details

• Device ID: K143469
• 510k Number: K143469
• Device Name: SOFTECH Plus ETCO2 Cannula
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: TELEFLEX MEDICAL, INC. 2917 WECK DRIVE Research Triangle, NC 27709
• Contact: Brian Gall
• Correspondent: Brian Gall; TELEFLEX MEDICAL, INC. 2917 WECK DRIVE Research Triangle, NC 27709
• Product Code: CCK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-05
• Decision Date: 2015-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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