The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ultranet-s Collimator.
Device ID | K894142 |
510k Number | K894142 |
Device Name: | ULTRANET-S COLLIMATOR |
Classification | Collimator, Automatic, Radiographic |
Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
Contact | Larry Kroger |
Correspondent | Larry Kroger GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
Product Code | IZW |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-13 |
Decision Date | 1989-11-06 |