Atlas FDA

EZ STIM

FDA 510(k) clearance K954505 · decided 1996-12-10

Clearance details

K-number
K954505
Device name
EZ STIM
Applicant
Life-Tech Intl., Inc.
Decision
Substantially Equivalent
Date received
1995-09-28
Decision date
1996-12-10
Days to decision
439 days
Clearance type
Traditional
Product code
KOI
Device class
2
Regulation number
868.2775
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Houston, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.