ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
FDA 510(k) clearance K151609 · decided 2015-11-06
Clearance details
- K-number
- K151609
- Device name
- ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
- Applicant
- Nds Surgical Imaging, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-06-15
- Decision date
- 2015-11-06
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.