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510(k) K960121

AUTOLINK BODY PLETHYSMOGRAPH by P.K. Morgan , Ltd. — Product Code BZC

K960121 is an FDA 510(k) premarket notification submitted by P.K. Morgan , Ltd. for the device "AUTOLINK BODY PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on January 9, 1997. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. P.K. Morgan , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1997
Date Received
January 11, 1996
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 P.K. Morgan , Ltd.

  • K954730 — BENCHMARK TRANSFER TEST (April 1, 1997)
  • K954731 — OXYLOG 2 (January 6, 1997)
  • K953990 — TRANSFLOW TEST (December 9, 1996)

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