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510(k) K043138

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 by Atos Medical AB — Product Code EWL

K043138 is an FDA 510(k) premarket notification submitted by Atos Medical AB for the device "PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134". The FDA issued a decision of Substantially Equivalent on November 22, 2004. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Atos Medical AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2004
Date Received
November 12, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Laryngeal (Taub)
Device Class
Class II
Regulation Number
874.3730
Review Panel
EN
Submission Type

Other clearances by Atos Medical AB

  • K151404 — ProTrach Dualcare (February 12, 2016)
  • K141380 — PROVOX FREEHANDS FLEXIVOICE (September 26, 2014)
  • K131947 — PROVOX VEGA PUNCTURE SET (October 18, 2013)
  • K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (October 14, 2010)
  • K090455 — PROVOX VEGA, MODEL 8130-8135 (June 5, 2009)
  • K072582 — PROVOX MICRON HME (May 30, 2008)
  • K022125 — PROVOX FREEHANDS HME, MODEL 7710 (July 30, 2002)
  • K014102 — PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 (February 21, 2002)
  • K971244 — PROVOX 2 VOICE PROSTHESIS SYSTEM (June 6, 1997)
  • K942495 — SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM (February 21, 1995)

Other clearances for product code EWL

  • K240763 — FirstFit Surgical Kit (December 18, 2024)
  • K141380 — PROVOX FREEHANDS FLEXIVOICE (September 26, 2014)
  • K131947 — PROVOX VEGA PUNCTURE SET (October 18, 2013)
  • K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (October 14, 2010)
  • K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER (March 3, 2010)
  • K090455 — PROVOX VEGA, MODEL 8130-8135 (June 5, 2009)
  • K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20 (September 4, 2008)
  • K022125 — PROVOX FREEHANDS HME, MODEL 7710 (July 30, 2002)
  • K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (June 25, 1999)
  • K974132 — VOICE MASTER PROSTHESIS (February 25, 1998)

FDA data resources