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510(k) K800547

MEDISTOR III LUNG ANALYZER by Cybermedic, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1980
Date Received
March 10, 1980
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 Cybermedic, Inc.

  • K941813 — VENSHIELD (May 3, 1994)
  • K914205 — PFF-1 (May 1, 1992)
  • K903959 — NEONATAL METASCOPE (November 23, 1990)
  • K884910 — MODEL 1010, CY-MET (June 12, 1989)
  • K861418 — SPINNAKER (May 9, 1986)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)
  • K842782 — PHYSIOLOGICAL ANALYZER CM-710 (August 17, 1984)
  • K842760 — LUNG ANALYZER CM-310 (July 26, 1984)
  • K831586 — CM-VII PHYSIOLOGIC ANALYZER (March 19, 1984)
  • K790579 — MEDISTOR II (April 4, 1979)

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)