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 |