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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K864680
Device Name MOBIL 02
Applicant
Roman Laboratories, Inc.
3552 S. Olathe St.
Aurora,  CO  80013
Applicant Contact RAY ROMAN
Correspondent
Roman Laboratories, Inc.
3552 S. Olathe St.
Aurora,  CO  80013
Correspondent Contact RAY ROMAN
Regulation Number868.6250
Classification Product Code
BTI  
Date Received12/02/1986
Decision Date 01/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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