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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837494
Device Name BABY LIGHT METER
Applicant
Rocky Mountain Medical Corp.
20 Apollo Rd.
Montrose,  CO  81401
Correspondent
Rocky Mountain Medical Corp.
20 Apollo Rd.
Montrose,  CO  81401
Date Received04/19/1983
Decision Date 06/14/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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