The following data is part of a premarket notification filed by North East Monitoring Inc. with the FDA for Holter Lx Analysis.
| Device ID | K081861 |
| 510k Number | K081861 |
| Device Name: | HOLTER LX ANALYSIS |
| Classification | Ventilatory Effort Recorder |
| Applicant | NORTH EAST MONITORING INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary NORTH EAST MONITORING INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-01 |
| Decision Date | 2008-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M582NEMK1270 | K081861 | 000 |