DUALGUARD

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

FLEXICARE MEDICAL LTD.

The following data is part of a premarket notification filed by Flexicare Medical Ltd. with the FDA for Dualguard.

Pre-market Notification Details

• Device ID: K140473
• 510k Number: K140473
• Device Name: DUALGUARD
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: FLEXICARE MEDICAL LTD. CYNON VALLEY BUSINESS PARK MOUTAIN ASH Mid Glamorgan, GB Cf45 4er
• Contact: Christopher Watkins
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: CCK
• Subsequent Product Code: CAT
• Subsequent Product Code: MNK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2014-02-25
• Decision Date: 2014-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055788781776	K140473	000
05055788714729	K140473	000
05055788714705	K140473	000
05055788714682	K140473	000
05055788714668	K140473	000
05055788714644	K140473	000