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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K003067
Device Name CALEO
Applicant
DRAGER MEDIZINTECHNIK GMBH
3136 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JIM BRENNAN
Correspondent
DRAGER MEDIZINTECHNIK GMBH
3136 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JIM BRENNAN
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received10/02/2000
Decision Date 12/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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