Atlas FDA

MODEL 704

FDA 510(k) clearance K912139 · decided 1992-03-25

Clearance details

K-number
K912139
Device name
MODEL 704
Applicant
Ivy Biomedical Systems, Inc.
Decision
Substantially Equivalent
Date received
1991-05-14
Decision date
1992-03-25
Days to decision
316 days
Clearance type
Traditional
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Branford, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.