FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
K Number: K890513
·
Decision Apr 28, 1989
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
35
Applicant Total
6
Review Days
86
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Basic Information
- Device Name
- SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
- K Number
- K890513
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micro Tronics Corp.
- Date Received
- February 1, 1989
- Decision Date
- April 28, 1989
- Product Code
- OLZ
- 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 |
|---|---|---|---|
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Micro Tronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K901797 | THE WONDER BOX | Feb 7, 1991 | 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 |