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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 K801286
Device Name PORTA-NEB(R) 310
Applicant
E.B.E. RESEARCH & MFG., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
E.B.E. RESEARCH & MFG., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.6250
Classification Product Code
BTI  
Date Received05/30/1980
Decision Date 07/08/1980
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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