The following data is part of a premarket notification filed by Ilife Systems, Inc. with the FDA for Hannah Wireless Vital Signs Monitor.
| Device ID | K991087 |
| 510k Number | K991087 |
| Device Name: | HANNAH WIRELESS VITAL SIGNS MONITOR |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | ILIFE SYSTEMS, INC. 5910 N. CENTRAL EXPRESSWAY SUITE 1775 Dallas, TX 75206 |
| Contact | Joshua A Adler |
| Correspondent | Joshua A Adler ILIFE SYSTEMS, INC. 5910 N. CENTRAL EXPRESSWAY SUITE 1775 Dallas, TX 75206 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 2000-01-12 |
| Summary: | summary |