The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for X-ray High Voltage Generator Ed 125l.
Device ID | K920730 |
510k Number | K920730 |
Device Name: | X-RAY HIGH VOLTAGE GENERATOR ED 125L |
Classification | Generator, High-voltage, X-ray, Diagnostic |
Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
Contact | De Mint |
Correspondent | De Mint SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
Product Code | IZO |
CFR Regulation Number | 892.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-18 |
Decision Date | 1992-04-27 |