FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
K Number: K922064
·
Decision Dec 1, 1992
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
36
Applicant Total
27
Review Days
211
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Basic Information
- Device Name
- MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
- K Number
- K922064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardiotronics, Inc.
- Date Received
- May 4, 1992
- Decision Date
- December 1, 1992
- Product Code
- GXD
- 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 |
|---|---|---|---|
| GXD | Generator, Lesion, Radiofrequency | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXD), ordered by most recent decision date.
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
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FDA Class 2
·Neurology
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FDA 510(k)
FDA Class 2
·Neurology
Racz Neurostat RF Generator
FDA 510(k)
FDA Class 2
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FDA 510(k)
FDA Class 2
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APEX 6
FDA 510(k)
FDA Class 2
·Neurology
Abbott Medical Grounding Pad, model RF-DGP-IS
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Cardiotronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932903 | EKG VEST | Feb 24, 1995 | Substantially Equivalent |
| K923297 | MODEL #340 STEALTH-TRODE+LS | Sep 18, 1992 | Substantially Equivalent |
| K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) | Jun 11, 1992 | Substantially Equivalent |
| K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE | Jun 11, 1992 | Substantially Equivalent |
| K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) | Jun 11, 1992 | Substantially Equivalent |
| K921606 | MODEL #125 CHILD STIMULATION PADS | May 26, 1992 | Substantially Equivalent |
| K920086 | SHOCK-PATCH ADULT DEFIBRILLATION PADS | Feb 3, 1992 | Substantially Equivalent |
| K914725 | COORDINATOR, CABLE INPUT | Nov 5, 1991 | Substantially Equivalent |
| K911456 | MODEL #110 STEALTH-TRODE CHILD DEFIB PADS | Oct 16, 1991 | Substantially Equivalent |
| K912621 | MODEL #911 STEALTH MULTI PADS | Oct 16, 1991 | Substantially Equivalent |