FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
K Number: K964451
·
Decision Nov 27, 1996
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
21
Review Days
21
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Basic Information
- Device Name
- PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
- K Number
- K964451
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rexton, Inc.
- Date Received
- November 6, 1996
- Decision Date
- November 27, 1996
- 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 Rexton, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970537 | REXTON MODEL 48 AND 49PP | Mar 28, 1997 | Substantially Equivalent |
| K960295 | LONG LIFE RX-12 | Mar 22, 1996 | Substantially Equivalent |
| K954922 | REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS | Jan 17, 1996 | Substantially Equivalent |
| K953770 | REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY | Sep 18, 1995 | Substantially Equivalent |
| K950451 | M-29 PP-PC, M-29 PP-O/PC | Mar 21, 1995 | Substantially Equivalent |
| K944851 | MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC | Feb 22, 1995 | Substantially Equivalent |
| K944777 | ORION PPM, PP, PP-D | Dec 30, 1994 | Substantially Equivalent |
| K944359 | EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12 | Dec 29, 1994 | Substantially Equivalent |
| K942702 | DEEP CANAL HEARING INSTRUMENT | Dec 21, 1994 | Substantially Equivalent |
| K944548 | REXPLUS PP3 | Nov 14, 1994 | Substantially Equivalent |