The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Vupad.
Device ID | K140199 |
510k Number | K140199 |
Device Name: | VUPAD |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | SONOMED, INC. 1979 MARCUS AVE., SUITE 105C Lake Success, NY 11042 |
Contact | Charles C O'neal |
Correspondent | Charles C O'neal SONOMED, INC. 1979 MARCUS AVE., SUITE 105C Lake Success, NY 11042 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-27 |
Decision Date | 2014-04-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00896100002170 | K140199 | 000 |
00896100002026 | K140199 | 000 |
00896100002033 | K140199 | 000 |
00896100002040 | K140199 | 000 |
00896100002057 | K140199 | 000 |
00896100002064 | K140199 | 000 |
00896100002125 | K140199 | 000 |
00896100002132 | K140199 | 000 |
00896100002149 | K140199 | 000 |
00896100002156 | K140199 | 000 |
00896100002163 | K140199 | 000 |
00896100002019 | K140199 | 000 |