The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Sls Simulator (models Sls-9 And Sls-14).
Device ID | K891293 |
510k Number | K891293 |
Device Name: | SLS SIMULATOR (MODELS SLS-9 AND SLS-14) |
Classification | System, Simulation, Radiation Therapy |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | William G Mcmahon |
Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | KPQ |
CFR Regulation Number | 892.5840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-10 |
Decision Date | 1989-04-20 |