FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K Number: K043138
·
Decision Nov 22, 2004
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
39
Applicant Total
15
Review Days
10
Basic Information
- Device Name
- PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
- K Number
- K043138
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3730
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ATOS MEDICAL AB
- Date Received
- November 12, 2004
- Decision Date
- November 22, 2004
- Product Code
- EWL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by ATOS MEDICAL AB
| K Number | Device Name | ||
|---|---|---|---|
| K151404 | ProTrach Dualcare | Feb 12, 2016 | Substantially Equivalent |
| K141380 | PROVOX FREEHANDS FLEXIVOICE | Sep 26, 2014 | Substantially Equivalent |
| K131947 | PROVOX VEGA PUNCTURE SET | Oct 18, 2013 | Substantially Equivalent |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | Oct 14, 2010 | Unknown |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | Jun 5, 2009 | Substantially Equivalent |
| K072582 | PROVOX MICRON HME | May 30, 2008 | Substantially Equivalent |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | Jul 30, 2002 | Substantially Equivalent |
| K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | Feb 21, 2002 | Substantially Equivalent |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | Jun 6, 1997 | Substantially Equivalent |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | Feb 21, 1995 | Substantially Equivalent |