FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ELPHA 2000
K Number: K914231
·
Decision May 28, 1992
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
9
Review Days
251
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Basic Information
- Device Name
- ELPHA 2000
- K Number
- K914231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biometer Intl. A/S
- Date Received
- September 20, 1991
- Decision Date
- May 28, 1992
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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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 |
| 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 |
| K860187 | MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING | Mar 20, 1986 | Substantially Equivalent |