The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Prosound 6 Diagnostic Ultrasound System.
| Device ID | K080176 |
| 510k Number | K080176 |
| Device Name: | ALOKA PROSOUND 6 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 | 2008-01-24 |
| Decision Date | 2008-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122955416 | K080176 | 000 |
| 04562122955362 | K080176 | 000 |
| 04562122954778 | K080176 | 000 |
| 04562122954211 | K080176 | 000 |
| 04562122953962 | K080176 | 000 |
| 04573596212769 | K080176 | 000 |
| 04573596212462 | K080176 | 000 |
| 04573596213193 | K080176 | 000 |
| 04573596213247 | K080176 | 000 |