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510(k) K011344

INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 by Collins Medical, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2002
Date Received
May 2, 2001
Clearance Type
Abbreviated
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 Collins Medical, Inc.

  • K030917 — GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 (May 14, 2003)
  • K030464 — GEM, MODEL 004110 (March 14, 2003)
  • K992743 — COLLINS CPL (September 13, 1999)

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)