FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICOLET MAPLELEAF SYSTEM
K Number: K905632
·
Decision Jun 7, 1991
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
13
Review Days
172
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Basic Information
- Device Name
- NICOLET MAPLELEAF SYSTEM
- K Number
- K905632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Nicolet Instrument Corp.
- Date Received
- December 17, 1990
- Decision Date
- June 7, 1991
- Product Code
- GWJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Nicolet Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K921138 | NICOLET ULTRASOM ACQUISITION STATION | May 14, 1993 | Substantially Equivalent |
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| K915652 | NICOLET PORATBLE SPIRIT SYSTEM | Feb 7, 1992 | Substantially Equivalent |
| K897154 | NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE | Apr 30, 1990 | 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 |