8ch Wrist Coil

Coil, Magnetic Resonance, Specialty

Invivo Corporation (Business Trade Name: Philips)

The following data is part of a premarket notification filed by Invivo Corporation (business Trade Name: Philips) with the FDA for 8ch Wrist Coil.

Pre-market Notification Details

Device IDK222325
510k NumberK222325
Device Name:8ch Wrist Coil
ClassificationCoil, Magnetic Resonance, Specialty
Applicant Invivo Corporation (Business Trade Name: Philips) 3545 SW 47th Ave Gainesville,  FL  32608
ContactConnie Pascual
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-08-02
Decision Date2022-08-31

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