The following data is part of a premarket notification filed by Pie Medical with the FDA for Mylab 15 / Mylab 20, Model 2700.
| Device ID | K043588 |
| 510k Number | K043588 |
| Device Name: | MYLAB 15 / MYLAB 20, MODEL 2700 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| 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 | No |
| Combination Product | No |
| Date Received | 2004-12-28 |
| Decision Date | 2005-01-25 |
| Summary: | summary |