FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
K Number: K930498
·
Decision Dec 12, 1994
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
15
Review Days
679
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Basic Information
- Device Name
- NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
- K Number
- K930498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Neuromed, Inc.
- Date Received
- February 1, 1993
- Decision Date
- December 12, 1994
- Product Code
- GZB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
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Other Clearances by Neuromed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960728 | ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) | May 22, 1996 | Substantially Equivalent |
| K930536 | NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC | Dec 15, 1994 | Substantially Equivalent |
| K930242 | INTRODE INT-8 | Feb 2, 1994 | Substantially Equivalent |
| K921319 | NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 | May 5, 1993 | Substantially Equivalent |
| K905596 | NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST | Mar 11, 1991 | Substantially Equivalent |
| K905255 | NEUROMED MODEL 1992 LS LAMITRODE LEAD | Jan 25, 1991 | Substantially Equivalent |
| K903814 | NEUROMED TS8 TEST STIMULATOR | Jan 16, 1991 | Substantially Equivalent |
| K901499 | NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO. | Jun 29, 1990 | Substantially Equivalent |
| K862915 | MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL) | Oct 6, 1986 | Substantially Equivalent |
| K860185 | UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER | Apr 4, 1986 | Substantially Equivalent |