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510(k) K062754

GAS MODULE SE, MODEL 0998-00-0481-02 by Datascope Corp. — Product Code BZK

K062754 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "GAS MODULE SE, MODEL 0998-00-0481-02". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Datascope Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2006
Date Received
September 14, 2006
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 Datascope Corp.

  • K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (December 26, 2019)
  • K181122 — CARDIOSAVE Intra-Aortic Balloon Pump (May 31, 2018)
  • K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (October 12, 2017)
  • K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Batter (January 31, 2017)
  • K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (July 2, 2015)
  • K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND A (December 12, 2013)
  • K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX (September 25, 2007)
  • K062569 — SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING (February 14, 2007)
  • K062098 — SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX (February 5, 2007)
  • K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 IN (January 5, 2007)

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