TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +

Transmitters And Receivers, Electrocardiograph, Telephone

ROZINN ELECTRONICS, INC.

The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Telephone Electrocardiograph Transmitter And Receiver, Ttm For Windows +.

Pre-market Notification Details

• Device ID: K061780
• 510k Number: K061780
• Device Name: TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale, NY 11385
• Contact: Mark Rosoff
• Correspondent: Mark Rosoff; ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale, NY 11385
• Product Code: DXH
• CFR Regulation Number: 870.2920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-26
• Decision Date: 2006-09-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00856298006206	K061780	000
00856298006190	K061780	000
00856298006114	K061780	000