The following data is part of a premarket notification filed by Lifeclinic International, Inc. with the FDA for Lifeclinic, Model 2400.
| Device ID | K040562 |
| 510k Number | K040562 |
| Device Name: | LIFECLINIC, MODEL 2400 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LIFECLINIC INTERNATIONAL, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers LIFECLINIC INTERNATIONAL, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-03 |
| Decision Date | 2004-08-31 |
| Summary: | summary |