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510(k) K864885

SPIROVISION by Futuremed Div. of Future Impex Corp. — Product Code BZM

K864885 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "SPIROVISION". The FDA issued a decision of Substantially Equivalent on January 15, 1987. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1987
Date Received
December 12, 1986
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 Futuremed Div. of Future Impex Corp.

  • K933511 — UPGRADED SPIROMETER ST-90 (February 10, 1994)
  • K933220 — SELECTOR SL 01 (November 24, 1993)
  • K933222 — AUDIOMETER DA 323 (November 1, 1993)
  • K903017 — MEGA-TENS DUAL CHANNEL T.E.N.S. (October 26, 1990)
  • K901308 — SPIRO ANALYZER MODEL ST 250 (July 23, 1990)
  • K884972 — TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR (July 27, 1989)
  • K871421 — MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT (January 22, 1988)
  • K873817 — SPIRO ANALYZER ST-300 (December 2, 1987)
  • K872044 — CARBON ELECTRODE (July 16, 1987)
  • K872045 — CONDUCTIVITY GEL (July 15, 1987)

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