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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K990960
Device Name PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
Applicant
Perimed, Inc.
14900 Sweitzer Ln.
Laurel,  MD  20707
Applicant Contact JAMES HOWARD
Correspondent
Perimed, Inc.
14900 Sweitzer Ln.
Laurel,  MD  20707
Correspondent Contact JAMES HOWARD
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Code
KLK  
Date Received03/22/1999
Decision Date 09/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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