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510(k) K851706

UNIVERSAL COMPUTER INTERFACE SYSTEM by Vacumetrics, Inc. — Product Code BZM

K851706 is an FDA 510(k) premarket notification submitted by Vacumetrics, Inc. for the device "UNIVERSAL COMPUTER INTERFACE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 3, 1985. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Vacumetrics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type

Other clearances by Vacumetrics, Inc.

  • K864852 — VISTA INTERFACE SYSTEM (March 4, 1987)
  • K860844 — VISTA INTERFACE SYSSTEM (April 2, 1986)

Other clearances for product code BZM

  • K102229 — PULMOTRACK 2020 SYSTEM (March 4, 2011)
  • K090863 — PERSONAL WHEEZOMETER (September 21, 2009)
  • K071955 — WIM-PC, MODEL 1010 (November 1, 2007)
  • K012387 — STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM (April 23, 2002)
  • K980878 — PULMOTRACK,MODEL 1010 (December 28, 1998)
  • K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM (July 21, 1998)
  • K955432 — CPX, CCM, CATH WITH 15% CO2 (July 1, 1996)
  • K923209 — MEDGRAPHICS EXERCISE CONSULT (March 11, 1993)
  • K911143 — PB100 DIAGNOSTIC SPIROMETER (November 29, 1991)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)

FDA data resources