The following data is part of a premarket notification filed by Lakeview Sleep Center with the FDA for Nasal Comfort Freedom.
Device ID | K130686 |
510k Number | K130686 |
Device Name: | NASAL COMFORT FREEDOM |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | LAKEVIEW SLEEP CENTER 400 NORTH RAND RD North Barrington, IL 60010 |
Contact | Andy Black |
Correspondent | Andy Black LAKEVIEW SLEEP CENTER 400 NORTH RAND RD North Barrington, IL 60010 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-13 |
Decision Date | 2013-10-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NASAL COMFORT FREEDOM 85295967 not registered Dead/Abandoned |
Buddharaju, Venkata 2011-04-15 |