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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K141967
Device Name PUREFILL OXYGEN COMPRESSOR
Applicant
INOVO, INC.
401 Leonard Blvd N
Lehigh Acres,  FL  33971
Applicant Contact PAUL DRYDEN
Correspondent
INOVO, INC.
401 Leonard Blvd N
Lehigh Acres,  FL  33971
Correspondent Contact PAUL DRYDEN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/21/2014
Decision Date 11/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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