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510(k) K790185

MODEL V 4207 INTEGRATING PLUG-IN by Electronics For Medicine, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1979
Date Received
January 29, 1979
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 Electronics For Medicine, Inc.

  • K830791 — UNIVERSAL MEDDARS SYSTEM (June 22, 1983)
  • K830795 — CABINET FOR MULTIPLE FUNCTION BLOCKS (May 18, 1983)
  • K792528 — RESPIRATION/APNEA AMPLIFIER MODEL 3105 (February 21, 1980)
  • K791006 — SMART BILECTRODES (June 11, 1979)
  • K790198 — MONITOR PLUG-IN MODEL M1106 ECG (March 6, 1979)
  • K790203 — INTERVAL TIMER MODEL V4295 (March 2, 1979)
  • K780107 — ANALYZER-PLUG-IN, CO2 MODEL M 3104 (January 30, 1978)
  • K770366 — ISOLATED ELECTROCARDIOGRAPH MODEL 1207 (March 1, 1977)

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  • 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)