The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq P5 And A5.
Device ID | K060993 |
510k Number | K060993 |
Device Name: | GE LOGIQ P5 AND A5 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Allen Schuh |
Correspondent | Allen Schuh GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-11 |
Decision Date | 2006-05-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682119856 | K060993 | 000 |