The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Galemed Cpap Mask.
Device ID | K072755 |
510k Number | K072755 |
Device Name: | GALEMED CPAP MASK |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | GALEMED CORP. 3460 POINTE CREEK COURT SUITE 102 Bonita Springs, FL 34134 -2015 |
Contact | Paul Dryden |
Correspondent | Paul Dryden GALEMED CORP. 3460 POINTE CREEK COURT SUITE 102 Bonita Springs, FL 34134 -2015 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-27 |
Decision Date | 2007-11-16 |
Summary: | summary |