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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K832127
Device Name NAUTILUS MONOPLACE HYPERBARIC UNIT
Applicant
Nautilus Environmedical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Nautilus Environmedical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5470
Classification Product Code
CBF  
Date Received07/01/1983
Decision Date 08/12/1983
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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