The following data is part of a premarket notification filed by Newman Medical with the FDA for Simpleabi.
| Device ID | K110628 |
| 510k Number | K110628 |
| Device Name: | SIMPLEABI |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | NEWMAN MEDICAL 5350 VIVIAN STREET UNIT C Arvada, CO 80002 |
| Contact | Spencer Newman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852785008654 | K110628 | 000 |
| 00852785008647 | K110628 | 000 |
| 00852785008630 | K110628 | 000 |
| 00852785008623 | K110628 | 000 |
| 00852785008616 | K110628 | 000 |
| 00852785008609 | K110628 | 000 |
| 00852785008661 | K110628 | 000 |