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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 46923980110502 | K072755 | 000 |
| 44710810089747 | K072755 | 000 |
| 44710810110175 | K072755 | 000 |
| 44710810112452 | K072755 | 000 |
| 44710810112667 | K072755 | 000 |
| 44710810112674 | K072755 | 000 |
| 44710810115880 | K072755 | 000 |
| 46923980104747 | K072755 | 000 |
| 46923980110496 | K072755 | 000 |
| 24710810084946 | K072755 | 000 |