Home / 510(k) Clearances / K884910

510(k) K884910

MODEL 1010, CY-MET by Cybermedic, Inc. — Product Code BZK

K884910 is an FDA 510(k) premarket notification submitted by Cybermedic, Inc. for the device "MODEL 1010, CY-MET". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Cybermedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
November 25, 1988
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 Cybermedic, Inc.

  • K941813 — VENSHIELD (May 3, 1994)
  • K914205 — PFF-1 (May 1, 1992)
  • K903959 — NEONATAL METASCOPE (November 23, 1990)
  • K861418 — SPINNAKER (May 9, 1986)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)
  • K842782 — PHYSIOLOGICAL ANALYZER CM-710 (August 17, 1984)
  • K842760 — LUNG ANALYZER CM-310 (July 26, 1984)
  • K831586 — CM-VII PHYSIOLOGIC ANALYZER (March 19, 1984)
  • K800547 — MEDISTOR III LUNG ANALYZER (March 25, 1980)
  • K790579 — MEDISTOR II (April 4, 1979)

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