FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PMT TRUSCAN SURFACE ELECTRODE
K Number: K122376
·
Decision Dec 19, 2012
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
20
Review Days
135
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Basic Information
- Device Name
- PMT TRUSCAN SURFACE ELECTRODE
- K Number
- K122376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pmt Corp.
- Date Received
- August 6, 2012
- Decision Date
- December 19, 2012
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Pmt Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K090733 | PMT HALO SYSTEM | Jul 28, 2009 | Substantially Equivalent |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | May 8, 2009 | Substantially Equivalent |
| K042901 | ENDOMARK STERILE INDIA INK | Mar 16, 2005 | Substantially Equivalent |
| K033730 | PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES | Aug 3, 2004 | Substantially Equivalent |
| K972597 | PMT NEW BEGINNINGS GELSHAPES & AMEND | Oct 1, 1997 | Substantially Equivalent |
| K970418 | PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) | Apr 29, 1997 | Substantially Equivalent |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | Mar 19, 1997 | Substantially Equivalent |
| K935560 | PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) | Nov 7, 1994 | Substantially Equivalent |
| K933079 | ELECTROCAUTERY SYSTEM MODEL 1980 | Feb 22, 1994 | Substantially Equivalent |
| K935499 | PMT SILICONE SHEETING | Feb 10, 1994 | Substantially Equivalent |