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510(k) K001631

CORTEX METAMAX by Cortex Biophysik GmbH — Product Code BZC

K001631 is an FDA 510(k) premarket notification submitted by Cortex Biophysik GmbH for the device "CORTEX METAMAX". The FDA issued a decision of Substantially Equivalent on February 22, 2001. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Cortex Biophysik GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2001
Date Received
May 26, 2000
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 Cortex Biophysik GmbH

  • K993641 — METALYZER, MODEL 2; METALYZER, MODEL 3 (December 14, 2000)

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