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510(k) K963327

TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 by Novametrix Medical Systems, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1996
Date Received
August 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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  • K963380 — CO 2 SMO PLUS (January 22, 1997)
  • K960831 — VENTRAK RMMS 1550 (May 29, 1996)
  • K924626 — NOVAMETRIX MODEL 510 (December 3, 1993)
  • K920379 — NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX (July 15, 1992)
  • K913516 — MODEL 520A NOVAMETRIX PULSE OXIMETER (November 4, 1991)

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