The following data is part of a premarket notification filed by Penrith Corporation with the FDA for Penrith Elettra Ultrasound System.
| Device ID | K100598 |
| 510k Number | K100598 |
| Device Name: | PENRITH ELETTRA ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PENRITH CORPORATION 5170 CAMPUS DRIVE SUITE 2 Plymouth Meeting, PA 19462 |
| Contact | Lawrence Engle |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2010-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869003337 | K100598 | 000 |
| 04056869003320 | K100598 | 000 |
| 04056869003207 | K100598 | 000 |
| 04056869002736 | K100598 | 000 |