The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Model 330 Multifunction Aspirator.
Device ID | K170533 |
510k Number | K170533 |
Device Name: | Model 330 Multifunction Aspirator |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
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 | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-23 |
Decision Date | 2017-04-18 |
Summary: | summary |