The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Power Infuser.
Device ID | K172653 |
510k Number | K172653 |
Device Name: | Power Infuser |
Classification | Pump, Infusion |
Applicant | ZOLL Medical Corporation 269 & 271 Mill Road Chelmsford, MA 01824 -4105 |
Contact | Pooja Dalvi |
Correspondent | Pooja Dalvi ZOLL Medical Corporation 269 & 271 Mill Road Chelmsford, MA 01824 -4105 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-05 |
Decision Date | 2018-07-18 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POWER INFUSER 78008764 2567483 Live/Registered |
ZOLL MEDICAL CORPORATION 2000-05-18 |