The following data is part of a premarket notification filed by Lifewatch Systems, Inc. with the FDA for Infaguard Tm.
| Device ID | K854705 |
| 510k Number | K854705 |
| Device Name: | INFAGUARD TM |
| Classification | Monitor, Breathing Frequency |
| Applicant | LIFEWATCH SYSTEMS, INC. 8937 S.E. JANNSEN RD. Clackamas, OR 97015 |
| Contact | Freda Whitesel |
| Correspondent | Freda Whitesel LIFEWATCH SYSTEMS, INC. 8937 S.E. JANNSEN RD. Clackamas, OR 97015 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-21 |
| Decision Date | 1986-05-01 |