VITALSENSE

Thermometer, Electronic, Clinical

MINI-MITTER CO., INC.

The following data is part of a premarket notification filed by Mini-mitter Co., Inc. with the FDA for Vitalsense.

Pre-market Notification Details

• Device ID: K033534
• 510k Number: K033534
• Device Name: VITALSENSE
• Classification: Thermometer, Electronic, Clinical
• Applicant: MINI-MITTER CO., INC. 20300 EMPIRE AVE. BLDG. B-3 Bend, OR 97701
• Contact: Jack E Mckenzie
• Correspondent: Jack E Mckenzie; MINI-MITTER CO., INC. 20300 EMPIRE AVE. BLDG. B-3 Bend, OR 97701
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-10
• Decision Date: 2004-04-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00606959021648	K033534	000
00606959033337	K033534	000