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510(k) K001502

AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO by Erich Jaeger GmbH — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2000
Date Received
May 15, 2000
Clearance Type
Special
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

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  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
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  • K972419 — TOENNIES NEUROSCREEN SYSTEM (April 30, 1998)
  • K960078 — ASTHMA MONITOR (September 20, 1996)

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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)