The following data is part of a premarket notification filed by Pom Medical, Llc with the FDA for Panoramic Oxygen Mask (pom).
Device ID | K172365 |
510k Number | K172365 |
Device Name: | Panoramic Oxygen Mask (POM) |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | Pom Medical, LLC 1230 Madera Rd., Suite 5, Box 101 Simi Valley, CA 92065 |
Contact | Jeff Voss |
Correspondent | Paul Dryden Pom Medical, LLC C/o ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, FL 33704 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-04 |
Decision Date | 2018-04-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10851438008239 | K172365 | 000 |
20851438008038 | K172365 | 000 |
20851438008045 | K172365 | 000 |
20851438008052 | K172365 | 000 |
20851438008069 | K172365 | 000 |
20851438008076 | K172365 | 000 |
20851438008106 | K172365 | 000 |
20851438008113 | K172365 | 000 |
20851438008120 | K172365 | 000 |
20851438008137 | K172365 | 000 |
20851438008144 | K172365 | 000 |
20851438008151 | K172365 | 000 |
10851438008178 | K172365 | 000 |
10851438008185 | K172365 | 000 |
10851438008192 | K172365 | 000 |
10851438008208 | K172365 | 000 |
10851438008215 | K172365 | 000 |
10851438008222 | K172365 | 000 |
20851438008021 | K172365 | 000 |