Home / 510(k) Clearances / K974805

510(k) K974805

CO-STAT(TM) END TIDAL BREATH ANALYZER by Natus Medical, Inc. — Product Code GHS

K974805 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "CO-STAT(TM) END TIDAL BREATH ANALYZER". The FDA issued a decision of Substantially Equivalent on March 11, 1998. The device falls under product code GHS (Assay, Carboxyhemoglobin), a Class II device regulated under 21 CFR 864.7425. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1998
Date Received
December 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Carboxyhemoglobin
Device Class
Class II
Regulation Number
864.7425
Review Panel
HE
Submission Type

Other clearances by Natus Medical, Inc.

  • K093304 — PROTEKTOR 32 (August 11, 2010)
  • K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)
  • K090019 — NATUS NEUROWORKS, MODEL 104196 (February 22, 2010)
  • K083371 — NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) (December 8, 2009)
  • K073665 — ALGO 5 NEWBORN HEARING SCREENER (January 25, 2008)
  • K051869 — NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (October 7, 2005)
  • K030823 — ALGO 3I NEWBORN HEARING SCREENER (April 9, 2003)
  • K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNIT (September 19, 2002)
  • K013137 — ALGO 3 NEWBORN HEARING SCREENER (October 16, 2001)
  • K935160 — MINIMUFFS (February 9, 1995)

Other clearances for product code GHS

  • K910827 — ABL520 BLOOD GAS SYSTEM (July 9, 1991)
  • K790943 — TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (June 22, 1979)
  • K771263 — RADIOMHTER OSM-2 HEMOXIMETER (August 3, 1977)
  • K770209 — ECOLYZER CARBOXIMETER (March 7, 1977)

FDA data resources