Atlas FDA

OMED IDENT-I-BAND

FDA 510(k) clearance K830484 · decided 1983-03-24

Clearance details

K-number
K830484
Device name
OMED IDENT-I-BAND
Applicant
Omega-Med Intl., Inc.
Decision
Substantially Equivalent
Date received
1983-02-15
Decision date
1983-03-24
Days to decision
37 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.