FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3-CHANNEL K-AMP
K Number: K934449
·
Decision Oct 8, 1993
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
24
Review Days
28
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Basic Information
- Device Name
- 3-CHANNEL K-AMP
- K Number
- K934449
- 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
- Argosy Electronics
- Date Received
- September 10, 1993
- Decision Date
- October 8, 1993
- 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 Argosy Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Jan 20, 1998 | Substantially Equivalent |
| K971699 | ARGOSY DYNAMEQ | Jul 3, 1997 | Substantially Equivalent |
| K961729 | ARGOSY PROGRAMMABLE | May 29, 1996 | Substantially Equivalent |
| K954038 | K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT | Sep 18, 1995 | Substantially Equivalent |
| K952452 | OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL | Jul 6, 1995 | Substantially Equivalent |
| K952451 | CLASS D LINEAR WITH ACTIVE TONE CONTROL | Jul 6, 1995 | Substantially Equivalent |
| K952450 | WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL | Jul 6, 1995 | Substantially Equivalent |
| K952454 | EXPANDER WITH ACTIVE TONE CONTROL | Jun 21, 1995 | Substantially Equivalent |
| K952455 | IMPROVED MANHATTAN II | Jun 21, 1995 | Substantially Equivalent |
| K952453 | INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL | Jun 21, 1995 | Substantially Equivalent |