FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
K Number: K897154
·
Decision Apr 30, 1990
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
13
Review Days
125
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Basic Information
- Device Name
- NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
- K Number
- K897154
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Nicolet Instrument Corp.
- Date Received
- December 26, 1989
- Decision Date
- April 30, 1990
- 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 Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K921138 | NICOLET ULTRASOM ACQUISITION STATION | May 14, 1993 | Substantially Equivalent |
| K923315 | NICOLET ARK SYSTEM | Nov 23, 1992 | Substantially Equivalent |
| K921927 | NICOLET VOYAGEUR | Nov 5, 1992 | Substantially Equivalent |
| K915652 | NICOLET PORATBLE SPIRIT SYSTEM | Feb 7, 1992 | Substantially Equivalent |
| K905632 | NICOLET MAPLELEAF SYSTEM | Jun 7, 1991 | Substantially Equivalent |
| K894629 | NICOLET BEAM II SYSTEM | Mar 9, 1990 | Substantially Equivalent |
| K896477 | NICOLET REAL EAR ANALYZER | Feb 8, 1990 | Substantially Equivalent |
| K883781 | NICOLET NEUROPORT/ACE SYSTEM | Jun 5, 1989 | Substantially Equivalent |
| K890495 | NICOLET VIKING II SYSTEM | Mar 16, 1989 | Substantially Equivalent |
| K884294 | NICOLET NYSTAR PLUS SYSTEM | Nov 23, 1988 | Substantially Equivalent |