The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Sleepap.
Device ID | K905593 |
510k Number | K905593 |
Device Name: | SLEEPAP |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel, IA 50003 |
Contact | Russell F Bird |
Correspondent | Russell F Bird MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel, IA 50003 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-13 |
Decision Date | 1991-04-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SLEEPAP 88016916 5675137 Live/Registered |
Encompass Group, LLC 2018-06-27 |