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510(k) K863866

RESPIRADYNE II(TM) by Chesebrough-Pond'S U.S.A. Co. — Product Code BZK

K863866 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "RESPIRADYNE II(TM)". The FDA issued a decision of Substantially Equivalent on January 28, 1987. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1987
Date Received
October 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

Other clearances by Chesebrough-Pond'S U.S.A. Co.

  • K862803 — CHESEBROUGH POND'S HYDROCOLLOID DRESSING (November 14, 1986)
  • K851382 — CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING (July 5, 1985)
  • K851383 — BLISTERFILM TRANSPARENT DRESSING (July 5, 1985)
  • K851539 — CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO (June 12, 1985)
  • K843567 — KANGAROO NASOGASTRIC FEEDING TUBE (February 14, 1985)
  • K845010 — CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (January 15, 1985)
  • K844186 — CONTINENT STOMA SYSTEM & ACCESSORIES (January 15, 1985)
  • K843128 — FEMALE URINARY INCONTINENCE SYS (January 2, 1985)
  • K844789 — KANGAROO ACCESS II ENTERAL FEEDING CONTAINER (January 2, 1985)
  • K843139 — ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND (November 8, 1984)

Other clearances for product code BZK

  • K192584 — BEACON Caresystem Model 00002144 (December 18, 2019)
  • K192595 — ExSpiron 2Xi (December 17, 2019)
  • K180788 — Gas Module 3 (October 24, 2018)
  • K173181 — ExSpiron 1Xi (March 16, 2018)
  • K162131 — ExSpiron 1Xi (May 9, 2017)
  • K130170 — EXSPIRON 1XI (May 29, 2013)
  • K120087 — EXSPIRON (September 26, 2012)
  • K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (June 2, 2011)
  • K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01 (September 21, 2009)
  • K092217 — MERCURY VCO2 (August 21, 2009)

FDA data resources