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510(k) K971134

Device
VISTA EYESHOWER
Applicant
JOHN BRANCH
510(k) number
K971134
Product code
LXO  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-04
Date received
1997-03-28
Regulation
510(k) Premarket Notification
Classification name
Analyzer, Hydrogen Gas
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Anesthesiology
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GRACE HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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