The following data is part of a premarket notification filed by Medtel Pty. Ltd. with the FDA for Hsh/h512 Adult Physiological Monitors.
| Device ID | K791838 |
| 510k Number | K791838 |
| Device Name: | HSH/H512 ADULT PHYSIOLOGICAL MONITORS |
| Classification | Computer, Blood-pressure |
| Applicant | MEDTEL PTY. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-14 |
| Decision Date | 1979-10-01 |