The following data is part of a premarket notification filed by Lifewatch Systems, Inc. with the FDA for Lifewatch Sensor Belt.
Device ID | K864487 |
510k Number | K864487 |
Device Name: | LIFEWATCH SENSOR BELT |
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 | 1986-11-13 |
Decision Date | 1987-01-28 |