The following data is part of a premarket notification filed by Zmed, Inc. with the FDA for Zmed Vp4000.
Device ID | K130929 |
510k Number | K130929 |
Device Name: | ZMED VP4000 |
Classification | System, Image Processing, Radiological |
Applicant | ZMED, INC. 9820 SUMMERS RIDGE RD San Diego, CA 92121 |
Contact | Randall S Millar |
Correspondent | Randall S Millar ZMED, INC. 9820 SUMMERS RIDGE RD San Diego, CA 92121 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-03 |
Decision Date | 2013-04-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00869958000124 | K130929 | 000 |