Company
United StatesZONARE Medical Systems, Inc., Mountain View, CA – FDA Inspections
Inspection records and compliance data for ZONARE Medical Systems, Inc. in Mountain View, California. 2 FDA inspections on record, last inspected April 16, 2015.
Company Profile
This profile covers ZONARE Medical Systems, Inc. based in Mountain View, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 28, 2011. Last inspected April 16, 2015.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- Documentation1 inspection
- Info evaluated to determine if event was reportable1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 16, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 922473 |
| July 28, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 739039 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ZONARE Medical Systems, Inc.
FEI Number
3004189859
Address
420 Bernardo Ave, Mountain View, California 94043, United States
Country
United States
ID: 1b07f2fd-5fab-41e1-8897-44291399ef81