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FDA 510(k), K150504, GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
FDA 510(k), K150504, GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
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$149.00 USD
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$149.00 USD
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510(K) Number: K150504
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
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
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