The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Netlink/netscan.
| Device ID | K020213 |
| 510k Number | K020213 |
| Device Name: | NETLINK/NETSCAN |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale, NY 11385 |
| Contact | Mark Rosoff |
| Correspondent | Mark Rosoff ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale, NY 11385 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-22 |
| Decision Date | 2002-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856298006183 | K020213 | 000 |
| 00856298006435 | K020213 | 000 |
| 00856298006428 | K020213 | 000 |