The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Meddars/ultra Imager Respiration Module.
Device ID | K812667 |
510k Number | K812667 |
Device Name: | MEDDARS/ULTRA IMAGER RESPIRATION MODULE |
Classification | Monitor, Breathing Frequency |
Applicant | HONEYWELL, INC. 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 | 1981-09-21 |
Decision Date | 1981-10-23 |