The following data is part of a premarket notification filed by Scientific & General Pty. Ltd. with the FDA for Monitor Hs8.
Device ID | K782044 |
510k Number | K782044 |
Device Name: | MONITOR HS8 |
Classification | Monitor, Breathing Frequency |
Applicant | SCIENTIFIC & GENERAL PTY. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-08 |
Decision Date | 1979-01-10 |