FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Z22
K Number: K953048
·
Decision Aug 15, 1995
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
73
Review Days
46
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Basic Information
- Device Name
- Z22
- K Number
- K953048
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Electone, Inc.
- Date Received
- June 30, 1995
- Decision Date
- August 15, 1995
- Product Code
- ESD
- 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Electone, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973266 | Z DEQ-II | Sep 23, 1997 | Substantially Equivalent |
| K961084 | AM 400 | Apr 18, 1996 | Substantially Equivalent |
| K955702 | SONATA U-01 | Feb 22, 1996 | Substantially Equivalent |
| K953050 | Z33 | Aug 22, 1995 | Substantially Equivalent |
| K953047 | Z20 | Aug 22, 1995 | Substantially Equivalent |
| K953053 | AM 260 PP | Aug 15, 1995 | Substantially Equivalent |
| K953052 | AM 260 K-AMP | Aug 15, 1995 | Substantially Equivalent |
| K953054 | AM 260 OHM | Aug 15, 1995 | Substantially Equivalent |
| K953051 | Z35 | Aug 15, 1995 | Substantially Equivalent |
| K953049 | Z24 | Aug 15, 1995 | Substantially Equivalent |