FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOEMG II AND BIOJVA
K Number: K003176
·
Decision Jan 4, 2001
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
10
Review Days
85
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Basic Information
- Device Name
- BIOEMG II AND BIOJVA
- K Number
- K003176
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Research Associates, Inc.
- Date Received
- October 11, 2000
- Decision Date
- January 4, 2001
- 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 Bio-Research Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130158 | M-SCAN | Jul 25, 2013 | Substantially Equivalent |
| K082927 | BIOEMG III | Feb 6, 2009 | Substantially Equivalent |
| K061799 | QUADRATENS, MODEL QT-42 | Aug 28, 2006 | Substantially Equivalent |
| K991756 | 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE | Dec 10, 1999 | Substantially Equivalent |
| K981563 | BIOPAK MEASUREMENT SYSTEM | Sep 15, 1998 | Substantially Equivalent |
| K952218 | JT-3 ELECTROGNATHOGRAPH | Sep 21, 1995 | Substantially Equivalent |
| K873947 | BIO-EMG MODEL 800 | Apr 27, 1988 | Substantially Equivalent |
| K844618 | BIO-TENS | Aug 21, 1985 | Substantially Equivalent |
| K822565 | NEEDLE CATHETER JEJUNOSTOMY KIT | Sep 28, 1982 | Substantially Equivalent |