FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
K Number: K921919
·
Decision Jan 7, 1993
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
6
Review Days
259
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Basic Information
- Device Name
- MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
- K Number
- K921919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Myo-Tronics, Inc.
- Date Received
- April 23, 1992
- Decision Date
- January 7, 1993
- Product Code
- KZM
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| KZM | Device, Muscle Monitoring | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZM), ordered by most recent decision date.
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FDA 510(k)
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Other Clearances by Myo-Tronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | Apr 2, 1997 | Substantially Equivalent |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | Dec 9, 1994 | Substantially Equivalent |
| K922270 | PHYSIOTECH 4000 OR NORODYN 8000 | Sep 2, 1994 | Substantially Equivalent |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Jun 9, 1994 | Substantially Equivalent for Some Indications |
| K905449 | ELECTROSONOGRAM ESG-1 | Apr 26, 1991 | Substantially Equivalent |