EASYFLOW

Monitor, Breathing Frequency

EPM INFORMATION SYSTEMS, INC.

The following data is part of a premarket notification filed by Epm Information Systems, Inc. with the FDA for Easyflow.

Pre-market Notification Details

• Device ID: K922112
• 510k Number: K922112
• Device Name: EASYFLOW
• Classification: Monitor, Breathing Frequency
• Applicant: EPM INFORMATION SYSTEMS, INC. 5212 HIGHBERRY WOODS RD. Midlothian, VA 23112
• Contact: Stephen A Burton
• Correspondent: Stephen A Burton; EPM INFORMATION SYSTEMS, INC. 5212 HIGHBERRY WOODS RD. Midlothian, VA 23112
• Product Code: BZQ
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-05-05
• Decision Date: 1992-12-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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