The following data is part of a premarket notification filed by Medtel Pty. Ltd. with the FDA for Hs17/hs18 Series Monitors.
| Device ID | K820670 |
| 510k Number | K820670 |
| Device Name: | HS17/HS18 SERIES MONITORS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDTEL PTY. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-11 |
| Decision Date | 1982-04-09 |