HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)

System, Hemodialysis, Access Recirculation Monitoring

TRANSONIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Hd01-series Transonic Hemodialysis Monitor (r%,qa,co,qb,qb2).

Pre-market Notification Details

• Device ID: K960817
• 510k Number: K960817
• Device Name: HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
• Classification: System, Hemodialysis, Access Recirculation Monitoring
• Applicant: TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850
• Contact: Cornelis J Drost
• Correspondent: Cornelis J Drost; TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850
• Product Code: MQS
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-02-28
• Decision Date: 1997-02-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00877466000451	K960817	000
00877466000437	K960817	000
08774660000459	K960817	000
08774660000442	K960817	000
08774660000435	K960817	000
08774660000428	K960817	000