FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NICOLET DIGITAL TWO PIECE HEARING AID
K Number: K873736
·
Decision Dec 8, 1987
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
26
Review Days
84
Basic Information
- Device Name
- NICOLET DIGITAL TWO PIECE HEARING AID
- K Number
- K873736
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- NICOLET BIOMEDICAL INSTRUMENTS
- Date Received
- September 15, 1987
- Decision Date
- December 8, 1987
- 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 NICOLET BIOMEDICAL INSTRUMENTS
| K Number | Device Name | ||
|---|---|---|---|
| K880573 | MODIFIED NICOLET VIKING SYSTEM | Mar 22, 1988 | Substantially Equivalent |
| K873964 | NICOLET DISPOSABLE PRASS PROBE | Nov 20, 1987 | Substantially Equivalent |
| K873535 | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM | Oct 26, 1987 | Substantially Equivalent |
| K871678 | NICOLET AMP 6R11 SYSTEM | Jul 16, 1987 | Substantially Equivalent |
| K862592 | PHOENIX SYSTEM SEVEN. | Sep 16, 1986 | Substantially Equivalent |
| K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES | Nov 27, 1985 | Substantially Equivalent |
| K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE | Apr 11, 1985 | Substantially Equivalent |
| K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | Apr 11, 1985 | Substantially Equivalent |
| K850259 | ELECTROENCEPHALOGRAPH EEG | Apr 11, 1985 | Substantially Equivalent |
| K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF | Apr 11, 1985 | Substantially Equivalent |