Rhythmlink Disposable Concentric Stimulating Probe
FDA 510(k) K132138 · Rhythmlink International, LLC
510(k) numberK132138
Submission
- Device name
- Rhythmlink Disposable Concentric Stimulating Probe
- Applicant
- Rhythmlink International, LLC
Columbia, SC, US - Received
- July 11, 2013
- Decision date
- April 11, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDQ – Neurosurgical Nerve Locator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
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Questions and answers
When was Rhythmlink Disposable Concentric Stimulating Probe cleared by the FDA?
Rhythmlink Disposable Concentric Stimulating Probe (K132138) received a 510(k) decision of Substantially Equivalent on April 11, 2014, 274 days after the submission was received.
What is the product code of K132138?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.