The following data is part of a premarket notification filed by 3b Medical, Inc. with the FDA for Luna® G3 Bpap 25a.
Device ID | K201620 |
510k Number | K201620 |
Device Name: | Luna® G3 BPAP 25A |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | 3B Medical, Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881 |
Contact | Yasser Estafanous |
Correspondent | Yasser Estafanous 3B Medical, Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-15 |
Decision Date | 2021-01-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() LUNA 90359348 not registered Live/Pending |
LUNA HEALTH, INC., 2020-12-04 |
![]() LUNA 90266081 not registered Live/Pending |
Fathom CC, LLC 2020-10-20 |
![]() LUNA 90206979 not registered Live/Pending |
Amazon Technologies, Inc. 2020-09-24 |
![]() LUNA 90206969 not registered Live/Pending |
Amazon Technologies, Inc. 2020-09-24 |
![]() LUNA 90188772 not registered Live/Pending |
E&T Horizons Limited Liability Company 2020-09-17 |
![]() LUNA 90163353 not registered Live/Pending |
Suzanna Djukic 2020-09-07 |
![]() LUNA 90098441 not registered Live/Pending |
Curriculum Associates, LLC 2020-08-06 |
![]() LUNA 90012957 not registered Live/Pending |
Whitaker, Lance 2020-06-22 |
![]() LUNA 88873593 not registered Live/Pending |
Luna Wellness LLC 2020-04-15 |
![]() LUNA 88872250 not registered Live/Pending |
Luna Wellness 2020-04-15 |
![]() LUNA 88865785 not registered Live/Pending |
Concordia Investment Partners, LLC 2020-04-09 |
![]() LUNA 88863834 not registered Live/Pending |
Concordia Investment Partners, LLC 2020-04-08 |