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 |