The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for Myopach Ultrasonic Pachometer.
| Device ID | K844112 |
| 510k Number | K844112 |
| Device Name: | MYOPACH ULTRASONIC PACHOMETER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MYOCURE, INC. 3253 SAN FERNADO RD. Los Angeles, CA 90065 |
| Contact | Alexa C Jensen |
| Correspondent | Alexa C Jensen MYOCURE, INC. 3253 SAN FERNADO RD. Los Angeles, CA 90065 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1986-01-16 |