ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)

Probe, Blood-flow, Extravascular

INTERNATIONAL BIOPHYSICS CORP.

The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Accuflo Monitoring System (1800)/ Accuflo Probe (8000).

Pre-market Notification Details

• Device ID: K963703
• 510k Number: K963703
• Device Name: ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
• Classification: Probe, Blood-flow, Extravascular
• Applicant: INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744
• Contact: H. David Shockley, Jr.
• Correspondent: H. David Shockley, Jr.; INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744
• Product Code: DPT
• CFR Regulation Number: 870.2120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-16
• Decision Date: 1998-04-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814321020186	K963703	000
00814321020162	K963703	000
10814321020176	K963703	000
10814321020152	K963703	000