FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINI-LOGGER SERIES 2000
K Number: K991045
·
Decision Sep 21, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
22
Applicant Total
5
Review Days
176
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Basic Information
- Device Name
- MINI-LOGGER SERIES 2000
- K Number
- K991045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1845
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mini-Mitter Co., Inc.
- Date Received
- March 29, 1999
- Decision Date
- September 21, 1999
- Product Code
- GWK
- 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 |
|---|---|---|---|
| GWK | Conditioner, Signal, Physiological | FDA class 2 | Neurology |
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