The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Cardio Id+(rz153+).
| Device ID | K022540 |
| 510k Number | K022540 |
| Device Name: | CARDIO ID+(RZ153+) |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-01 |
| Decision Date | 2002-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250903201219 | K022540 | 000 |
| 04250903200298 | K022540 | 000 |
| 04250903200281 | K022540 | 000 |
| 04250903200274 | K022540 | 000 |
| 04250903200267 | K022540 | 000 |
| 04250903200250 | K022540 | 000 |
| 04250903200243 | K022540 | 000 |