AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR

Detector And Alarm, Arrhythmia

TZ MEDICAL, INC.

The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Area-ct, Tz Medical Mcot Ecg Monitor And Arrhythmia Detector.

Pre-market Notification Details

• Device ID: K102507
• 510k Number: K102507
• Device Name: AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
• Classification: Detector And Alarm, Arrhythmia
• Applicant: TZ MEDICAL, INC. 7272 SW DURHAM RD., #800 Portland, OR 97224
• Contact: John Lubisich
• Correspondent: John Lubisich; TZ MEDICAL, INC. 7272 SW DURHAM RD., #800 Portland, OR 97224
• Product Code: DSI
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-01
• Decision Date: 2011-06-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811331019698	K102507	000
00811331013931	K102507	000
00811331013887	K102507	000
00811331010060	K102507	000
00811331010251	K102507	000
00811331010268	K102507	000
00811331010527	K102507	000
00811331011531	K102507	000
00811331011555	K102507	000
00811331011562	K102507	000
00811331013993	K102507	000
00811331014037	K102507	000
00811331014051	K102507	000
00811331014082	K102507	000
00811331014099	K102507	000
00811331014105	K102507	000
00811331013917	K102507	000