The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Prousound 2 Diagnostic Ultrasound System.
| Device ID | K083254 |
| 510k Number | K083254 |
| Device Name: | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Richard Cehovsky |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2008-11-04 |
| Decision Date | 2008-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122957403 | K083254 | 000 |
| 04562122955058 | K083254 | 000 |
| 04562122955010 | K083254 | 000 |
| 04562122955003 | K083254 | 000 |
| 04562122954792 | K083254 | 000 |
| 04573596212820 | K083254 | 000 |
| 04573596213605 | K083254 | 000 |
| 04573596213551 | K083254 | 000 |
| 04573596213537 | K083254 | 000 |
| 04573596213452 | K083254 | 000 |
| 04573596213445 | K083254 | 000 |
| 04573596213070 | K083254 | 000 |
| 04573596212943 | K083254 | 000 |
| 04573596210659 | K083254 | 000 |
| 04573596210635 | K083254 | 000 |
| 04573596210611 | K083254 | 000 |
| 04562122955171 | K083254 | 000 |
| 04562122955195 | K083254 | 000 |
| 04562122957380 | K083254 | 000 |
| 04562122957366 | K083254 | 000 |
| 04562122957359 | K083254 | 000 |
| 04562122956673 | K083254 | 000 |
| 04562122955980 | K083254 | 000 |
| 04562122955898 | K083254 | 000 |
| 04562122955881 | K083254 | 000 |
| 04562122955874 | K083254 | 000 |
| 04562122955782 | K083254 | 000 |
| 04562122955744 | K083254 | 000 |
| 04562122955683 | K083254 | 000 |
| 04562122955676 | K083254 | 000 |
| 04562122955614 | K083254 | 000 |
| 04562122955393 | K083254 | 000 |
| 04562122955249 | K083254 | 000 |
| 04573596210604 | K083254 | 000 |