IntelliCuff

Cuff, Tracheal Tube, Inflatable

HAMILTON MEDICAL AG

The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Intellicuff.

Pre-market Notification Details

• Device ID: K150893
• 510k Number: K150893
• Device Name: IntelliCuff
• Classification: Cuff, Tracheal Tube, Inflatable
• Applicant: HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH 7402
• Contact: Steffen Boden
• Correspondent: Steffen Boden; HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH 7402
• Product Code: BSK
• CFR Regulation Number: 868.5750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-02
• Decision Date: 2016-01-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630002800839	K150893	000