GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor— 510(k) K150504
Substantially EquivalentPci 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.. Device class: 2.
Clearance details
- Applicant
- Pci Medical, Inc.
- Product code
- Code PSW
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deep River, CT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.