The following data is part of a premarket notification filed by Medtel Pty. Ltd. with the FDA for Portable Operat. Rm. Monitors Hs30/40.
| Device ID | K832356 |
| 510k Number | K832356 |
| Device Name: | PORTABLE OPERAT. RM. MONITORS HS30/40 |
| Classification | Cart, Emergency, Cardiopulmonary (excluding Equipment) |
| Applicant | MEDTEL PTY. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZN |
| CFR Regulation Number | 868.6175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-10-28 |