FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING
K Number: K860187
·
Decision Mar 20, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
62
Applicant Total
9
Review Days
57
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Basic Information
- Device Name
- MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING
- K Number
- K860187
- 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
- January 22, 1986
- Decision Date
- March 20, 1986
- 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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STIMPOD ST2-3010 NERVE STIMULATOR
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EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
FDA 510(k)
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Other Clearances by Biometer Intl. A/S
| K Number | Device Name | ||
|---|---|---|---|
| K925159 | TOF-GUARD TRANSMISSION MONITOR | Sep 1, 1993 | Substantially Equivalent |
| K914231 | ELPHA 2000 | May 28, 1992 | Substantially Equivalent |
| K892396 | MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR | Oct 3, 1989 | Substantially Equivalent |
| K893485 | ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR | Jul 28, 1989 | Substantially Equivalent |
| K890746 | MYOTEST DBS NERVE STIMULATOR | Jul 14, 1989 | Substantially Equivalent |
| K881196 | AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL | Jun 16, 1989 | Substantially Equivalent |
| K870619 | ACCELOGRAPH | Mar 16, 1987 | Substantially Equivalent |
| K860186 | MYOTEST - NERVE STIMULATOR | Mar 20, 1986 | Substantially Equivalent |