The following data is part of a premarket notification filed by Cybersonics, Inc. with the FDA for Shockpulse-se Lithotripsy System.
| Device ID | K171024 |
| 510k Number | K171024 |
| Device Name: | ShockPulse-SE Lithotripsy System |
| Classification | Lithotriptor, Ultrasonic |
| Applicant | Cybersonics, Inc. Knowledge Park, 5340 Fryling Road, Suite 101 Erie, PA 16510 |
| Contact | Samradni Patil |
| Correspondent | Samradni Patil Cybersonics, Inc. Knowledge Park, 5340 Fryling Road, Suite 101 Erie, PA 16510 |
| Product Code | FEO |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-05 |
| Decision Date | 2017-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925044203 | K171024 | 000 |
| 00821925043831 | K171024 | 000 |
| 00821925043718 | K171024 | 000 |
| 00821925043701 | K171024 | 000 |
| 00821925043695 | K171024 | 000 |
| 00821925043749 | K171024 | 000 |
| 00821925043732 | K171024 | 000 |
| 00821925043725 | K171024 | 000 |