The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Hd11 Diagnostic Ultrasound System.
Device ID | K043535 |
510k Number | K043535 |
Device Name: | HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
Contact | Steve Singlar |
Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
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 | Yes |
Combination Product | No |
Date Received | 2004-12-22 |
Decision Date | 2005-01-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838076754 | K043535 | 000 |
00884838068070 | K043535 | 000 |