The following data is part of a premarket notification filed by Aac Consulting Group, Inc. with the FDA for Aware Pad.
| Device ID | K991469 |
| 510k Number | K991469 |
| Device Name: | AWARE PAD |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | AAC CONSULTING GROUP, INC. 7475 WISCONSIN AVE., SUITE 850 Bethesda, MD 20814 |
| Contact | Eduardo March |
| Correspondent | Eduardo March AAC CONSULTING GROUP, INC. 7475 WISCONSIN AVE., SUITE 850 Bethesda, MD 20814 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-28 |
| Decision Date | 1999-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00083059012071 | K991469 | 000 |
| 00083059012033 | K991469 | 000 |
| 08305900012033 | K991469 | 000 |