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510(k) K001142

AUDIO TECHNOLOGIES S:R.1 by Audio Technologies S.R.L. — Product Code ETB

K001142 is an FDA 510(k) premarket notification submitted by Audio Technologies S.R.L. for the device "AUDIO TECHNOLOGIES S:R.1". The FDA issued a decision of Substantially Equivalent on June 23, 2000. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Audio Technologies S.R.L. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2000
Date Received
April 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

Other clearances by Audio Technologies S.R.L.

  • K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL0 (March 23, 2009)

Other clearances for product code ETB

  • K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (5 (April 3, 2026)
  • K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x (April 3, 2026)
  • K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis (January 17, 2025)
  • K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFI (January 17, 2025)
  • K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES P (December 2, 2013)
  • K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (February 8, 2013)
  • K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (April 17, 2008)
  • K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, (December 6, 2006)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)

FDA data resources