FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
THE VIRTUAL M-332
K Number: K960500
·
Decision Apr 3, 1996
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
13
Applicant Total
9
Review Days
61
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE VIRTUAL M-332
- K Number
- K960500
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Virtual Corp.
- Date Received
- February 2, 1996
- Decision Date
- April 3, 1996
- Product Code
- EWD
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EWD | Protector, Hearing (Insert) | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EWD), ordered by most recent decision date.
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
FDA 510(k)
FDA Unclassified
·Unknown
SUPER SILIPLUGS EAR PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
SILICONE PUTTY EAR PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
HEARSAVER
FDA 510(k)
FDA Unclassified
·Unknown
DOC'S PROPLUGS EAR PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
MODEL 322 CLINICAL AUDIOMETER
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Virtual Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934715 | MODEL 222 CLINICAL AUDIOMETER | May 10, 1994 | Substantially Equivalent |
| K930203 | MODEL 322 CLINICAL AUDIOMETER | Jul 8, 1993 | Substantially Equivalent |
| K926574 | MODEL 330 SCREENING AUDIO METER, MODIFIED | Mar 29, 1993 | Substantially Equivalent |
| K911689 | MODEL 330 SCREENING AUDIOMETER | Oct 21, 1991 | Substantially Equivalent |
| K895443 | MODEL 210 IMPEDANCE SYSTEM | Jan 16, 1990 | Substantially Equivalent |
| K896301 | MODEL 340 PROBE MIC SYSTEM | Jan 16, 1990 | Substantially Equivalent |
| K863984 | MODEL 320 TWO CHANNEL AUDIOMETER | Nov 18, 1986 | Substantially Equivalent |
| K853863 | MODEL 310 IMPEDANCE SYSTEM | Dec 18, 1985 | Substantially Equivalent |