SRS-200 RADIOSURGERY SYSTEM

Accelerator, Linear, Medical

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Srs-200 Radiosurgery System.

Pre-market Notification Details

Device IDK891292
510k NumberK891292
Device Name:SRS-200 RADIOSURGERY SYSTEM
ClassificationAccelerator, Linear, Medical
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactWilliam G Mcmahon
CorrespondentWilliam G Mcmahon
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-10
Decision Date1989-09-18

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