OSTOM-I ALERT

Collector, Ostomy

11 HEALTH AND TECHNOLOGIES LLC

The following data is part of a premarket notification filed by 11 Health And Technologies Llc with the FDA for Ostom-i Alert.

Pre-market Notification Details

• Device ID: K140938
• 510k Number: K140938
• Device Name: OSTOM-I ALERT
• Classification: Collector, Ostomy
• Applicant: 11 HEALTH AND TECHNOLOGIES LLC 1468 Harwell Avenue Crofton, MD 21114
• Contact: E J Smith
• Correspondent: E J Smith; 11 HEALTH AND TECHNOLOGIES LLC 1468 Harwell Avenue Crofton, MD 21114
• Product Code: EXB
• Subsequent Product Code: EZQ
• Subsequent Product Code: EZS
• CFR Regulation Number: 876.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-04-11
• Decision Date: 2014-10-10
• Summary: summary