The following data is part of a premarket notification filed by Apneicare, Llc with the FDA for Apneicare Connection Center/internet Analysis.
| Device ID | K082968 |
| 510k Number | K082968 |
| Device Name: | APNEICARE CONNECTION CENTER/INTERNET ANALYSIS |
| Classification | Ventilatory Effort Recorder |
| Applicant | APNEICARE, LLC 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden APNEICARE, LLC 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-06 |
| Decision Date | 2009-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G642CC1A0 | K082968 | 000 |