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510(k) K093662

ECHOBRIGHT by Life-Tech, Inc. — Product Code CAZ

K093662 is an FDA 510(k) premarket notification submitted by Life-Tech, Inc. for the device "ECHOBRIGHT". The FDA issued a decision of Substantially Equivalent on June 24, 2010. The device falls under product code CAZ (Anesthesia Conduction Kit), a Class II device regulated under 21 CFR 868.5140. Life-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2010
Date Received
November 25, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anesthesia Conduction Kit
Device Class
Class II
Regulation Number
868.5140
Review Panel
AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Life-Tech, Inc.

  • K120234 — EZONO 3000 (April 19, 2012)
  • K111355 — ECHOBRIGHT (September 16, 2011)
  • K102813 — EZONO 3000 (June 30, 2011)
  • K102007 — PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, (December 22, 2010)
  • K093485 — VESISCAN (March 16, 2010)
  • K082772 — STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC191 (February 9, 2009)
  • K082056 — ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 (November 7, 2008)
  • K082923 — PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, (October 24, 2008)
  • K081864 — PROLONG (September 25, 2008)
  • K073187 — PERIPHERAL NERVE BLOCK SUPPORT TRAY (April 22, 2008)

Other clearances for product code CAZ

  • K222341 — Arrow 0.2 Micron Flat Filter, GVS (February 13, 2023)
  • K210983 — BD Epilor Syringe (May 19, 2022)
  • K201356 — Plastic LOR Syringe (February 12, 2021)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)
  • K190345 — VPC (May 16, 2019)
  • K161075 — Arrow Epidural Catheter Kit (October 4, 2016)
  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K143581 — Arrow Epidural Catheter Kit (June 26, 2015)
  • K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (December 21, 2012)
  • K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN (September 14, 2012)

FDA data resources