Atlas FDA

GLAUKON

FDA 510(k) clearance K812015 · decided 1982-02-08

Clearance details

K-number
K812015
Device name
GLAUKON
Applicant
Sonometrics Systems, Inc.
Decision
Substantially Equivalent
Date received
1981-07-17
Decision date
1982-02-08
Days to decision
206 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.