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510(k) K964360

VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 by Novametrix Medical Systems, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1997
Date Received
November 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

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  • K982499 — COSMO PLUS WITH NICO, MODEL 8200 (October 16, 1998)
  • K963380 — CO 2 SMO PLUS (January 22, 1997)
  • K963327 — TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 (November 20, 1996)
  • 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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