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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K821667
Device Name SINGLE USE NON-CONDUCTIVE CIRC. DISCON
Applicant
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact Kerry J Savage
Correspondent
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact Kerry J Savage
Regulation Number868.2600
Classification Product Code
CAP  
Date Received06/07/1982
Decision Date 06/24/1982
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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