FDA 510(k) K150504, GUS ASTRA TEE and ASTRA VR Probe Reprocessors, by Pci Medical, Inc.
FDA 510(k) K150504, GUS ASTRA TEE and ASTRA VR Probe Reprocessors, by Pci Medical, Inc.
Device Name: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
Manufacturer: Pci Medical, Inc.
Device Classification Name: high level disinfection reprocessing instrument for ultrasonic transducers, liquid
Regulation Number: 892.1570
Classification Product Code: PSW
Date Received: 02/26/2015
Decision Date: 11/16/2015
Regulation Medical Specialty: Radiology
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details