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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K801087
Device Name NEONATAL BREATHING CIRCUIT SYSTEM
Applicant
ISOTHERMAL SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ISOTHERMAL SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5975
Classification Product Code
BZO  
Date Received05/07/1980
Decision Date 05/23/1980
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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