The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Cpap.
| Device ID | K090710 |
| 510k Number | K090710 |
| Device Name: | MERCURY CPAP |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | MERCURY MEDICAL 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MERCURY MEDICAL 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-18 |
| Decision Date | 2009-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043572140 | K090710 | 000 |
| 30641043574052 | K090710 | 000 |
| 10641043574065 | K090710 | 000 |
| 30641043570153 | K090710 | 000 |
| 30641043570160 | K090710 | 000 |
| 30641043570177 | K090710 | 000 |
| 30641043572157 | K090710 | 000 |
| 30641043572164 | K090710 | 000 |
| 30641043572171 | K090710 | 000 |
| 10641043571217 | K090710 | 000 |
| 10641043571286 | K090710 | 000 |
| 30641043570139 | K090710 | 000 |
| 30641043570146 | K090710 | 000 |
| 30641043572133 | K090710 | 000 |
| 30641043574045 | K090710 | 000 |