FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICOLET PORATBLE SPIRIT SYSTEM
K Number: K915652
·
Decision Feb 7, 1992
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
13
Review Days
51
Basic Information
- Device Name
- NICOLET PORATBLE SPIRIT SYSTEM
- K Number
- K915652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NICOLET INSTRUMENT CORP.
- Date Received
- December 18, 1991
- Decision Date
- February 7, 1992
- Product Code
- GWF
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, 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 |
| K923315 | NICOLET ARK SYSTEM | Nov 23, 1992 | Substantially Equivalent |
| K921927 | NICOLET VOYAGEUR | Nov 5, 1992 | Substantially Equivalent |
| K905632 | NICOLET MAPLELEAF SYSTEM | Jun 7, 1991 | 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 |