MAXO2 CU

Analyzer, Gas, Oxygen, Gaseous-phase

MAXTEC, INC.

The following data is part of a premarket notification filed by Maxtec, Inc. with the FDA for Maxo2 Cu.

Pre-market Notification Details

Device IDK063488
510k NumberK063488
Device Name:MAXO2 CU
ClassificationAnalyzer, Gas, Oxygen, Gaseous-phase
Applicant MAXTEC, INC. 3460 POINTE CREEK CT. # 102 Bonita Springs,  FL  34134
ContactPaul Dryden
CorrespondentPaul Dryden
MAXTEC, INC. 3460 POINTE CREEK CT. # 102 Bonita Springs,  FL  34134
Product CodeCCL  
CFR Regulation Number868.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-17
Decision Date2007-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817770021148 K063488 000
00817770020455 K063488 000
00817770020448 K063488 000
00817770020431 K063488 000
00817770020424 K063488 000
00817770020417 K063488 000
00817770020400 K063488 000
00817770020394 K063488 000
00817770020387 K063488 000
00817770020370 K063488 000
00817770025689 K063488 000
00817770020462 K063488 000
00817770020479 K063488 000
00817770020486 K063488 000
00817770021131 K063488 000
00817770020981 K063488 000
00853061006296 K063488 000
00817770020905 K063488 000
00817770020899 K063488 000
00817770020882 K063488 000
00817770020875 K063488 000
00817770020820 K063488 000
00817770020509 K063488 000
00817770020493 K063488 000
00817770025658 K063488 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.