FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
K Number: K892396
·
Decision Oct 3, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
9
Review Days
179
Basic Information
- Device Name
- MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
- K Number
- K892396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- BIOMETER INTL. A/S
- Date Received
- April 7, 1989
- Decision Date
- October 3, 1989
- Product Code
- BXN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | FDA class 2 | Anesthesiology |
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Other Clearances by BIOMETER INTL. A/S
| K Number | Device Name | ||
|---|---|---|---|
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| K881196 | AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL | Jun 16, 1989 | Substantially Equivalent |
| K870619 | ACCELOGRAPH | Mar 16, 1987 | Substantially Equivalent |
| K860187 | MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING | Mar 20, 1986 | Substantially Equivalent |
| K860186 | MYOTEST - NERVE STIMULATOR | Mar 20, 1986 | Substantially Equivalent |