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510(k) K771510

SERVO-PAK MOLEL 0030 by Isothermal Systems, Inc. — Product Code BXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1977
Date Received
August 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Water Vapor, Gaseous-Phase
Device Class
Class I
Regulation Number
868.1975
Review Panel
AN
Submission Type

Other clearances by Isothermal Systems, Inc.

  • K801087 — NEONATAL BREATHING CIRCUIT SYSTEM (May 23, 1980)

Other clearances for product code BXA

  • K760246 — ENDOTRACHEAL T CONNECTOR (August 4, 1976)