510(k) K880286

OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP by Richards Medical Co., Inc. — Product Code ESD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 23, 1988
Date Received: January 25, 1988
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hearing Aid, Air-Conduction, Prescription
Device Class: Class I
Regulation Number: 874.3300
Review Panel: EN
Submission Type

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

Other clearances by Richards Medical Co., Inc.

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K895241 — INTRAMEDULLARY HIP SCREW (January 4, 1990)
K884824 — TRICON-M TOTAL KNEE SYSTEM (November 21, 1989)
K896204 — ZIRCONIA CERAMIC HEAD ADD'L SIZES (November 20, 1989)
K895242 — PAPPAS TRI-FLANGE VENTILATION TUBE (November 17, 1989)
K893377 — RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS (November 16, 1989)
K885069 — ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) (September 1, 1989)
K892366 — POROUS GENESIS STEMMED TIBIAL COMPONENT (July 19, 1989)

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