510(k) K944041

PERSONAL HEARING SYSTEM by Resound Corp. — Product Code LRS

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)
K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)