GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor— 510(k) K150504

Substantially Equivalent

Pci Medical, Inc.

FDA 510(k) clearance K150504 for GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor, Substantially Equivalent on 2015-11-16. Applicant: Pci Medical, Inc..

Clearance details

Applicant: Pci Medical, Inc.
Product code: Code PSW
Advisory panel: Radiology
Date received: 2015-02-26
Decision date: 2015-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deep River, CT, US

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