Home / 510(k) Clearances / K842754

510(k) K842754

CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 by Custom Ultrasonics — Product Code FLG

K842754 is an FDA 510(k) premarket notification submitted by Custom Ultrasonics for the device "CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2". The FDA issued a decision of Substantially Equivalent on November 28, 1984. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Custom Ultrasonics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1984
Date Received
July 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Ultrasonic, Medical Instrument
Device Class
Class I
Regulation Number
880.6150
Review Panel
HO
Submission Type

Other clearances by Custom Ultrasonics

  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K162120 — Scope-Assist Flushing Sink (April 28, 2017)
  • K122172 — SYSTEM 83 PLUS (January 25, 2013)
  • K061430 — SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR (January 12, 2007)
  • K983017 — MODIFICATION TO SYSTEM 83 PLUS (September 22, 1998)

Other clearances for product code FLG

  • K944950 — KLENZYME (December 20, 1994)
  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K933149 — INSTRUMENT DETERGENT CONCENTRATE (February 16, 1994)
  • K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM (March 16, 1989)

FDA data resources