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510(k) K912946

COLLINS DIGITAL PULMONARY MANOMETER by Warren E. Collins, Inc. — Product Code BXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1992
Date Received
July 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Airway Pressure (Inspiratory Force)
Device Class
Class II
Regulation Number
868.1780
Review Panel
AN
Submission Type

Other clearances by Warren E. Collins, Inc.

  • K925459 — GS-MODULAR (GOLD STANDARD - MODULAR) (February 4, 1994)
  • 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)
  • K803069 — SHELL KRATON THERMO-PLASTIC RUBBER COMP. (December 22, 1980)

Other clearances for product code BXR

  • K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (September 11, 2008)
  • K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (February 3, 2004)
  • K904917 — THAYER MIP ADAPTER (January 28, 1991)
  • K901998 — DIGITAL MANOMETER (DM 50) (July 25, 1990)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)