FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIVO 200 DPS VIVOSCAN
K Number: K003364
·
Decision Jul 18, 2001
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
5
Review Days
264
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Basic Information
- Device Name
- VIVO 200 DPS VIVOSCAN
- K Number
- K003364
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vivosonic, Inc.
- Date Received
- October 27, 2000
- Decision Date
- July 18, 2001
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Vivosonic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Dec 19, 2024 | Substantially Equivalent |
| K080060 | VIVOSONIC NEUROSCREEN | Apr 4, 2008 | Substantially Equivalent |
| K043396 | INTEGRITY, MODEL V500 | Jan 24, 2005 | Substantially Equivalent |
| K033108 | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | Oct 27, 2003 | Substantially Equivalent |