FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICOLET VIKING II SYSTEM
K Number: K890495
·
Decision Mar 16, 1989
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
13
Review Days
43
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Basic Information
- Device Name
- NICOLET VIKING II SYSTEM
- K Number
- K890495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Nicolet Instrument Corp.
- Date Received
- February 1, 1989
- Decision Date
- March 16, 1989
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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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 |
| 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 |
| K884294 | NICOLET NYSTAR PLUS SYSTEM | Nov 23, 1988 | Substantially Equivalent |