The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Holter Plus.
| Device ID | K042463 |
| 510k Number | K042463 |
| Device Name: | HOLTER PLUS |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale, NY 11385 |
| Contact | Mark Rosoff |
| Correspondent | Chris Lavanchy CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2004-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856298006268 | K042463 | 000 |
| 00856298006237 | K042463 | 000 |
| 00856298006169 | K042463 | 000 |