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 |