Home / 510(k) Clearances / K842760

510(k) K842760

LUNG ANALYZER CM-310 by Cybermedic, Inc. — Product Code BZC

K842760 is an FDA 510(k) premarket notification submitted by Cybermedic, Inc. for the device "LUNG ANALYZER CM-310". The FDA issued a decision of Substantially Equivalent on July 26, 1984. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Cybermedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1984
Date Received
July 16, 1984
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)
  • K831586 — CM-VII PHYSIOLOGIC ANALYZER (March 19, 1984)
  • K800547 — MEDISTOR III LUNG ANALYZER (March 25, 1980)
  • 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)

FDA data resources