The following data is part of a premarket notification filed by Aloka Co. Ltd Usa with the FDA for Aloka Model Ssd-5500 V6.0 Ultrasound System.
| Device ID | K032875 |
| 510k Number | K032875 |
| Device Name: | ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ALOKA CO. LTD USA 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Richard J Cehovsky |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2003-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122957014 | K032875 | 000 |
| 04562122954983 | K032875 | 000 |
| 04562122954952 | K032875 | 000 |
| 04562122954785 | K032875 | 000 |
| 04562122954723 | K032875 | 000 |
| 04562122954686 | K032875 | 000 |
| 04562122954662 | K032875 | 000 |
| 04562122954280 | K032875 | 000 |
| 04562122954273 | K032875 | 000 |
| 04562122954242 | K032875 | 000 |
| 04562122955065 | K032875 | 000 |
| 04562122955089 | K032875 | 000 |
| 04562122956246 | K032875 | 000 |
| 04562122956215 | K032875 | 000 |
| 04562122956123 | K032875 | 000 |
| 04562122955546 | K032875 | 000 |
| 04562122955522 | K032875 | 000 |
| 04562122955478 | K032875 | 000 |
| 04562122955454 | K032875 | 000 |
| 04562122955430 | K032875 | 000 |
| 04562122955300 | K032875 | 000 |
| 04562122954150 | K032875 | 000 |