The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Membrane Humidifier.
Device ID | K873472 |
510k Number | K873472 |
Device Name: | MEMBRANE HUMIDIFIER |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
Contact | Anthony V Beran |
Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-28 |
Decision Date | 1988-01-19 |