HOLTER FOR WINDOWS
Computer, Diagnostic, Programmable
NORTHEAST MONITORING, INC.
The following data is part of a premarket notification filed by Northeast Monitoring, Inc. with the FDA for Holter For Windows.
Pre-market Notification Details
| Device ID | K930564 |
| 510k Number | K930564 |
| Device Name: | HOLTER FOR WINDOWS |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | NORTHEAST MONITORING, INC. 167 MAYNARD RD. Sudbury, MA 01776 |
| Contact | Mark Hubelbank |
| Correspondent | Mark Hubelbank NORTHEAST MONITORING, INC. 167 MAYNARD RD. Sudbury, MA 01776 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-03 |
| Decision Date | 1995-04-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M581NEMK1630 | K930564 | 000 |
| M581NEMK1620 | K930564 | 000 |
| M581NEMK1610 | K930564 | 000 |
| M581NEMK1600 | K930564 | 000 |
Trademark Results [HOLTER FOR WINDOWS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HOLTER FOR WINDOWS 75720441 not registered Dead/Abandoned |
NorthEast Monitoring, Inc. 1999-06-29 |
 HOLTER FOR WINDOWS 74461030 not registered Dead/Abandoned |
ROZINN ELECTRONICS, INC. 1993-11-22 |
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