The following data is part of a premarket notification filed by Arobella Medical, Llc with the FDA for Ar1000 Ultrasonic Wound Therapy System.
| Device ID | K062544 |
| 510k Number | K062544 |
| Device Name: | AR1000 ULTRASONIC WOUND THERAPY SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | AROBELLA MEDICAL, LLC 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott AROBELLA MEDICAL, LLC 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2007-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853077002244 | K062544 | 000 |
| 00853077002114 | K062544 | 000 |
| 00853077002107 | K062544 | 000 |
| 00853077002091 | K062544 | 000 |
| 00853077002077 | K062544 | 000 |
| 00853077002060 | K062544 | 000 |
| 00853077002039 | K062544 | 000 |
| 00853077002022 | K062544 | 000 |
| 00853077002015 | K062544 | 000 |
| 00853077002121 | K062544 | 000 |
| 00853077002138 | K062544 | 000 |
| 00853077002237 | K062544 | 000 |
| 00853077002220 | K062544 | 000 |
| 00853077002213 | K062544 | 000 |
| 10853077002203 | K062544 | 000 |
| 00853077002176 | K062544 | 000 |
| 00853077002169 | K062544 | 000 |
| 00853077002152 | K062544 | 000 |
| 00853077002145 | K062544 | 000 |
| 00853077002008 | K062544 | 000 |