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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Manual
510(k) Number K864667
Device Name PENOX HOSPITAL BED
Applicant
Penox Technologies, Inc.
One Penox Plz., Commerce Rd.
P.O. Box 785
Pittston,  PA  18640
Applicant Contact THANA A FRANCE
Correspondent
Penox Technologies, Inc.
One Penox Plz., Commerce Rd.
P.O. Box 785
Pittston,  PA  18640
Correspondent Contact THANA A FRANCE
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received12/02/1986
Decision Date 01/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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