Atlas FDA

VENOMETER

FDA 510(k) clearance K983900 · decided 1999-01-29

Clearance details

K-number
K983900
Device name
VENOMETER
Applicant
Advanced Medical Technology , Ltd.
Decision
Substantially Equivalent
Date received
1998-11-03
Decision date
1999-01-29
Days to decision
87 days
Clearance type
Abbreviated
Product code
JOM
Device class
2
Regulation number
870.2780
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Sandy, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.