FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE WONDER BOX
K Number: K901797
·
Decision Feb 7, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
6
Review Days
294
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Basic Information
- Device Name
- THE WONDER BOX
- K Number
- K901797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micro Tronics Corp.
- Date Received
- April 19, 1990
- Decision Date
- February 7, 1991
- Product Code
- GWL
- 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 |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | FDA class 2 | Neurology |
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Other Clearances by Micro Tronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890513 | SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) | Apr 28, 1989 | Substantially Equivalent |
| K863124 | MODEL 8 EEG PREAMPLIFIER | Nov 18, 1986 | Substantially Equivalent |
| K862527 | SLEEP ANALYZING COMPUTER | Oct 6, 1986 | Substantially Equivalent |
| K780838 | PERCI | Jul 17, 1978 | Substantially Equivalent |
| K772005 | MYOTONE EMG MONITOR | Nov 23, 1977 | Substantially Equivalent |