The following data is part of a premarket notification filed by Panasonic Healthcare Co., Ltd. with the FDA for Aida Diagnostic Ultrasound System.
Device ID | K103148 |
510k Number | K103148 |
Device Name: | AIDA DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Echo, 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 | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-25 |
Decision Date | 2011-03-11 |
Summary: | summary |