Atlas FDA

EMG RECORDING ELECTRODE ASSEMBLY

FDA 510(k) clearance K120342 · decided 2012-06-22

Clearance details

K-number
K120342
Device name
EMG RECORDING ELECTRODE ASSEMBLY
Applicant
Rhythmlink International, LLC
Decision
Substantially Equivalent
Date received
2012-02-03
Decision date
2012-06-22
Days to decision
140 days
Clearance type
Traditional
Product code
IKT
Device class
2
Regulation number
890.1385
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Columbia, SC, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (K112034)Carefusion 209, Inc.2011-08-12
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (K111131)Carefusion 209, Inc.2011-06-17
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE (K092973)Bionen S.A.S.2010-10-07
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (K093825)Ambu A/S2010-01-13
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (K091410)Spes Medica Srl2009-08-11
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R (K091055)Rhythmlink International, LLC2009-06-23
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Recalls involving this device

No recalls on record reference this clearance.