ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE

Thermometer, Electronic, Clinical

HUMAN TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Human Technologies, Inc. with the FDA for Accutemp(tm) Temp. Monitioring System Swallowable.

Pre-market Notification Details

• Device ID: K880639
• 510k Number: K880639
• Device Name: ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE
• Classification: Thermometer, Electronic, Clinical
• Applicant: HUMAN TECHNOLOGIES, INC. 300 THIRD AVENUE N. St Petersburg, FL 33701
• Contact: Michael Hazel
• Correspondent: Michael Hazel; HUMAN TECHNOLOGIES, INC. 300 THIRD AVENUE N. St Petersburg, FL 33701
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-02-16
• Decision Date: 1988-11-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857414006032	K880639	000
00857414006025	K880639	000
00857414006018	K880639	000
00857414006001	K880639	000
00857414006049	K880639	000