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510(k) K902788

CLEM TM by Arbo Medical, Inc. — Product Code FIB

K902788 is an FDA 510(k) premarket notification submitted by Arbo Medical, Inc. for the device "CLEM TM". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Arbo Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
June 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Transducer, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Arbo Medical, Inc.

  • K940323 — ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & (April 12, 1995)
  • K935437 — ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES (April 6, 1995)
  • K942905 — DISPOSABLE TEMPERATURE PROBE COVER (February 27, 1995)
  • K940302 — ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & L (November 30, 1994)
  • K940322 — ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE (November 28, 1994)
  • K935246 — ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES (November 16, 1994)
  • K935429 — ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES (November 1, 1994)
  • K935281 — ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES (September 6, 1994)
  • K905545 — ULTRASOUND TRANSMISSION GEL (March 29, 1991)
  • K901816 — PRESSURE TUBING AND ACCESSORIES (July 12, 1990)

Other clearances for product code FIB

  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (February 21, 2008)
  • K001971 — HEMODIALYSIS TUBING SETS (May 24, 2001)
  • K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (April 27, 2001)
  • K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (December 5, 2000)
  • K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (December 1, 2000)
  • K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (June 7, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)

FDA data resources