The following data is part of a premarket notification filed by Scottcare Corporation with the FDA for Chroma, Model: Rz153c.
| Device ID | K083382 |
| 510k Number | K083382 |
| Device Name: | CHROMA, MODEL: RZ153C |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135 |
| Contact | Timothy J Leyva |
| Correspondent | Timothy J Leyva SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-14 |
| Decision Date | 2009-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856298006312 | K083382 | 000 |
| 00856298006220 | K083382 | 000 |
| 00856298006107 | K083382 | 000 |
| 00856298006091 | K083382 | 000 |
| 00856298006015 | K083382 | 000 |
| 00856298006008 | K083382 | 000 |