The following data is part of a premarket notification filed by Storz with the FDA for Storz Compuscan Ab.
Device ID | K930278 |
510k Number | K930278 |
Device Name: | STORZ COMPUSCAN AB |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
Contact | Michael T Taggart |
Correspondent | Michael T Taggart STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-21 |
Decision Date | 1994-02-09 |