FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

RFG-DGP DISPOSABLE GROUNDING PADS

K Number: K923647 · Decision Nov 9, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
8
Applicant Total
56
Review Days
111

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Basic Information

Device Name
RFG-DGP DISPOSABLE GROUNDING PADS
K Number
K923647
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Radionics, Inc.
Date Received
July 21, 1992
Decision Date
November 9, 1992
Product Code
JOT
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JOT Electrode, Gel, Electrosurgical

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Other Clearances by Radionics, Inc.

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K992226 XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K001950 OPTICAL TRACKING SYSTEM (OTS)
K001700 XPLAN 2.1
K001431 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K000057 RADIONICS LUMBOPERITONEAL SHUNT
K993594 CONFORMAX MMLC VR1
K991399 RADIONICS MICROELECTRODE KIT
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