FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMNIMIC (R)
K Number: K912817
·
Decision Jul 26, 1991
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
18
Applicant Total
4
Review Days
66
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Basic Information
- Device Name
- SOMNIMIC (R)
- K Number
- K912817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Somnitec, Inc.
- Date Received
- May 21, 1991
- Decision Date
- July 26, 1991
- Product Code
- LEL
- 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 |
|---|---|---|---|
| LEL | Device, Sleep Assessment | FDA class 2 | Neurology |
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Other Clearances by Somnitec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911989 | GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. | Jul 30, 1991 | Substantially Equivalent |
| K912234 | SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION | Jul 22, 1991 | Substantially Equivalent |
| K911990 | ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. | Jun 21, 1991 | Substantially Equivalent |