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510(k) K780703

CUFF PACER by Omp Laboratories, Inc. — Product Code CBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1978
Date Received
April 25, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Air Embolism, Ultrasonic
Device Class
Class II
Regulation Number
868.2025
Review Panel
AN
Submission Type

Other clearances by Omp Laboratories, Inc.

  • K760402 — SYRINGE SET, 3-WAY THERMODILUTIN (August 23, 1976)