The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Healthdyne Model 16900 Infant Monitor.
Device ID | K821731 |
510k Number | K821731 |
Device Name: | HEALTHDYNE MODEL 16900 INFANT MONITOR |
Classification | Monitor, Breathing Frequency |
Applicant | HEALTHDYNE, 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 | 1982-06-01 |
Decision Date | 1982-07-13 |