The following data is part of a premarket notification filed by Panasonic Healthcare Co., Ltd. with the FDA for Aida Vi.8 Diagnostic Ultrasound Gm-72p00a, L13-5v1 Transducer.
| Device ID | K122009 |
| 510k Number | K122009 |
| Device Name: | AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PANASONIC HEALTHCARE CO., LTD. 2425 SQUAK MOUNTAIN LOOP SW Issaquah, WA 98027 |
| Contact | Ram Bedi |
| Correspondent | Ram Bedi PANASONIC HEALTHCARE CO., LTD. 2425 SQUAK MOUNTAIN LOOP SW Issaquah, WA 98027 |
| 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 | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2012-10-03 |
| Summary: | summary |