The following data is part of a premarket notification filed by Medtel Pty. Ltd. with the FDA for Hs10 Portable Operating Room Monitor.
Device ID | K802184 |
510k Number | K802184 |
Device Name: | HS10 PORTABLE OPERATING ROOM MONITOR |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | MEDTEL PTY. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-10 |
Decision Date | 1980-09-26 |