FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Q-MS NEUROMUSCULAR STIMULATOR
K Number: K912462
·
Decision Jun 4, 1992
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
8
Review Days
366
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Basic Information
- Device Name
- Q-MS NEUROMUSCULAR STIMULATOR
- K Number
- K912462
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quantitative Medicine, Inc.
- Date Received
- June 4, 1991
- Decision Date
- June 4, 1992
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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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 |
| K923255 | Q-SD | Oct 5, 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 |