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510(k) K982499

COSMO PLUS WITH NICO, MODEL 8200 by Novametrix Medical Systems, Inc. — Product Code BZC

K982499 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "COSMO PLUS WITH NICO, MODEL 8200". The FDA issued a decision of Substantially Equivalent on October 16, 1998. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1998
Date Received
July 20, 1998
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

Other clearances by Novametrix Medical Systems, Inc.

  • K010451 — NOVAMETRIX MARQUETTE COMPATIBLE SENSORS (April 25, 2001)
  • K000794 — MODIFICATION TO MARSPO2, MODEL 2001 (April 10, 2000)
  • K993979 — MARSPO2, MODEL 2001 (February 22, 2000)
  • K964360 — VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 (April 4, 1997)
  • 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)

Other clearances for product code BZC

  • K240293 — STS (September 17, 2024)
  • K183567 — Vyntus/SentrySuite Product Line (August 23, 2019)
  • K190853 — Vyntus BODY (August 16, 2019)
  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)

FDA data resources