Atlas FDA

MODELS EUROSUN 2400 AND 800

FDA 510(k) clearance K837139 · decided 1983-03-04

Clearance details

K-number
K837139
Device name
MODELS EUROSUN 2400 AND 800
Applicant
Eurosun Scaenda Sol
Decision
Substantially Equivalent
Date received
1983-01-11
Decision date
1983-03-04
Days to decision
52 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.