• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
1 1

FDA 510(k) K141770, LUNA CPAP AND AUTO-CPAP SYSTEM, by 3B Medical, Inc.

FDA 510(k) K141770, LUNA CPAP AND AUTO-CPAP SYSTEM, by 3B Medical, Inc.

$89.00 USD
$89.00 USD
Sale Sold out
510(K) Number: K141770
Device Name: LUNA CPAP AND AUTO-CPAP SYSTEM
Manufacturer: 3B Medical, Inc.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 07/01/2014
Decision Date: 04/22/2015
Regulation Medical Specialty: Anesthesiology
View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome