510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Resonance Technology Inc

Northridge, CA, US

RESONANCE TECHNOLOGY, INC. appears in FDA device records in Northridge, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Resonance Technology Inc in 2000.

Clearances by year, as a table
510(k) clearance decisions for Resonance Technology Inc, by decision year
YearClearances
20001
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K994351M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEMLNHSubstantially Equivalent

Registered establishments

FDA registered establishments for Resonance Technology Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20292991000306474RESONANCE TECHNOLOGY, INC.18121 PARTHENIA ST., NORTHRIDGE, CA 91325 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1824-2008Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System .Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.Terminated
Z-1823-2008Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain