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510(k) K944041

PERSONAL HEARING SYSTEM by Resound Corp. — Product Code LRS

K944041 is an FDA 510(k) premarket notification submitted by Resound Corp. for the device "PERSONAL HEARING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 27, 1994. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200. Resound Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
August 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
I.V. Start Kit
Device Class
Class II
Regulation Number
880.5200
Review Panel
SU
Submission Type

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 Resound Corp.

  • K984547 — DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS (March 19, 1999)
  • K974081 — RESOUND STEALTH CIC (December 12, 1997)
  • K974257 — RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) (December 12, 1997)
  • K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (July 3, 1997)
  • K970215 — AUDALLION II HEARING SYSTEM (March 31, 1997)
  • K964557 — RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (November 27, 1996)
  • K964115 — RESOUND CC4 PERSONAL HEARING SYSTEM (November 4, 1996)
  • K960680 — RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, (April 10, 1996)
  • K960684 — HEARING AID - AIR CONDUCTION (April 10, 1996)
  • K960052 — RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 (March 12, 1996)

Other clearances for product code LRS

  • K050654 — AMSINO I.V. START KIT (May 2, 2005)
  • K001879 — INFUSION IV SET (November 20, 2001)
  • K963722 — IV START KIT (November 27, 1996)
  • K951167 — EMS I.V. START KIT (May 16, 1995)
  • K950184 — B. BRAUN IV START KITS (March 15, 1995)
  • K943941 — SAFESTART VASCULAR ACCESS START KIT (October 20, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K942238 — I.V. STARTPAK VASCULAR ACCESS START KIT (June 3, 1994)
  • K941469 — IV START KIT (May 12, 1994)
  • K925017 — IV PREP KIT (NON-STERILE) (August 27, 1993)

FDA data resources