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510(k) K780328

PULMONARY FUNCTION TESTER, COMPUTERIZED by Warren E. Collins, Inc. — Product Code BZC

K780328 is an FDA 510(k) premarket notification submitted by Warren E. Collins, Inc. for the device "PULMONARY FUNCTION TESTER, COMPUTERIZED". The FDA issued a decision of Substantially Equivalent on March 14, 1978. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Warren E. Collins, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1978
Date Received
February 27, 1978
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 Warren E. Collins, Inc.

  • K925459 — GS-MODULAR (GOLD STANDARD - MODULAR) (February 4, 1994)
  • K912946 — COLLINS DIGITAL PULMONARY MANOMETER (January 15, 1992)
  • K871151 — THE SPIRA ELEKTRO 2 (May 15, 1987)
  • K861227 — COLLINS PNEUMOTACH PFT SYSTEM (June 5, 1986)
  • K852102 — COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM (July 31, 1985)
  • K831780 — METABOLIC EXERCISE TESTING SYSTEM (September 12, 1983)
  • K831778 — RS-RESIDUAL VOLUME SYSTEM (August 31, 1983)
  • K831777 — COLLINS DS (August 31, 1983)
  • K831779 — COLLINS EAGLE II (August 26, 1983)
  • K803053 — APEXLINE OF PULMONARY FUNCT. INSTRUM. (December 22, 1980)

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