The following data is part of a premarket notification filed by Curlview Igt, Llc with the FDA for Cardio-view.
Device ID | K083321 |
510k Number | K083321 |
Device Name: | CARDIO-VIEW |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | CURLVIEW IGT, LLC 1242 CHESTNUT ST. Newton, MA 02464 |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-11-11 |
Decision Date | 2008-11-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859589006039 | K083321 | 000 |
00859589006022 | K083321 | 000 |
00859589006015 | K083321 | 000 |
00859589006008 | K083321 | 000 |
00859589006046 | K083321 | 000 |