The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Corneo-scan Ii Cs2000.
Device ID | K844477 |
510k Number | K844477 |
Device Name: | STORZ CORNEO-SCAN II CS2000 |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Niles Ross |
Correspondent | Niles Ross STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-19 |
Decision Date | 1985-01-23 |