FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Q-SD
K Number: K923255
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
8
Review Days
95
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Basic Information
- Device Name
- Q-SD
- K Number
- K923255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quantitative Medicine, Inc.
- Date Received
- July 2, 1992
- Decision Date
- October 5, 1992
- Product Code
- GZJ
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Quantitative Medicine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963608 | QUANTITATIVE SENTINEL SYSTEM | Mar 11, 1997 | Substantially Equivalent |
| K960109 | QUANTITATIVE SENTINEL SYSTEM | Aug 1, 1996 | Substantially Equivalent |
| K912462 | Q-MS NEUROMUSCULAR STIMULATOR | Jun 4, 1992 | Substantially Equivalent |
| K912460 | Q-TENS | Nov 13, 1991 | Substantially Equivalent |
| K912463 | MICRO-Q | Nov 13, 1991 | Substantially Equivalent |
| K904603 | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM | Jan 25, 1991 | Substantially Equivalent |
| K833395 | SENTINEL SYSTEMS | Jan 10, 1984 | Substantially Equivalent |