GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

PCI MEDICAL, INC.

The following data is part of a premarket notification filed by Pci Medical, Inc. with the FDA for Gus Astra Tee Transesophageal Probe Reprocessor, Gus Astra Vr Endovaginal/endorectal Probe Reprocessor.

Pre-market Notification Details

• Device ID: K150504
• 510k Number: K150504
• Device Name: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
• Classification: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
• Applicant: PCI MEDICAL, INC. 6 WINTER AVE. Deep River, CT 06443
• Contact: Kevin Mader
• Correspondent: Kevin Mader; PCI MEDICAL, INC. 6 WINTER AVE. Deep River, CT 06443
• Product Code: PSW
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-26
• Decision Date: 2015-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841436111294	K150504	000
00841436111287	K150504	000