The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Compuscan 68k.
| Device ID | K861335 |
| 510k Number | K861335 |
| Device Name: | STORZ COMPUSCAN 68K |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Dan Regan |
| Correspondent | Dan Regan 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 | 1986-04-09 |
| Decision Date | 1986-06-30 |