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 |