FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL EM-2 BIOELECTRIC PROCESSOR
K Number: K830034
·
Decision Feb 9, 1983
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
8
Review Days
33
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Basic Information
- Device Name
- MODEL EM-2 BIOELECTRIC PROCESSOR
- K Number
- K830034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Myo-Tronics Research, Inc.
- Date Received
- January 7, 1983
- Decision Date
- February 9, 1983
- 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 |
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Other Clearances by Myo-Tronics Research, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842223 | J4 MYO-MONITOR | Nov 19, 1984 | Substantially Equivalent |
| K842224 | BNS 40 | Nov 19, 1984 | Substantially Equivalent |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Feb 10, 1984 | Substantially Equivalent |
| K831364 | TESTCORP RA | May 27, 1983 | Substantially Equivalent |
| K813533 | ELECTRIC MUSCLE STIMULATOR | Mar 5, 1982 | Substantially Equivalent |
| K810528 | MODEL EM-IR | Mar 31, 1981 | Substantially Equivalent |
| K770252 | MONITOR, MYO, MODEL J3 | Feb 18, 1977 | Substantially Equivalent |