The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Rozinn 151.
| Device ID | K903331 |
| 510k Number | K903331 |
| Device Name: | ROZINN 151 |
| 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 | 1990-07-25 |
| Decision Date | 1990-10-22 |