The following data is part of a premarket notification filed by Praxair Healthcare Services with the FDA for Grab 'n Go Plus, Grab 'n Go Digital.
Device ID | K132778 |
510k Number | K132778 |
Device Name: | GRAB 'N GO PLUS, GRAB 'N GO DIGITAL |
Classification | Cylinder, Compressed Gas, And Valve |
Applicant | PRAXAIR HEALTHCARE SERVICES 62 FOREST STREET, STE 300 Marlborough, MA 01752 |
Contact | Tina Wu, Ph.d. |
Correspondent | Tina Wu, Ph.d. PRAXAIR HEALTHCARE SERVICES 62 FOREST STREET, STE 300 Marlborough, MA 01752 |
Product Code | ECX |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-05 |
Decision Date | 2014-07-07 |
Summary: | summary |