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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K770123
Device Name EXERCISE RESPIRATORY GAS ANALYZER
Applicant
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Correspondent
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/21/1977
Decision Date 02/01/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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