The following data is part of a premarket notification filed by Lifewatch Systems, Inc. with the FDA for Lifewatch(r) Portable Monitoring System.
| Device ID | K864419 |
| 510k Number | K864419 |
| Device Name: | LIFEWATCH(R) PORTABLE MONITORING SYSTEM |
| Classification | Monitor, Breathing Frequency |
| Applicant | LIFEWATCH SYSTEMS, INC. MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | William A Morton |
| Correspondent | William A Morton LIFEWATCH SYSTEMS, INC. MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-10 |
| Decision Date | 1987-03-16 |