The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for 731 Series Ventilators.
Device ID | K162832 |
510k Number | K162832 |
Device Name: | 731 Series Ventilators |
Classification | Ventilator, Continuous, Facility Use |
Applicant | ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Chuck Kolifrath |
Correspondent | Chuck Kolifrath ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD Chelmsford, MA 01824 -4105 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-11 |
Decision Date | 2017-08-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847946024130 | K162832 | 000 |
00847946023904 | K162832 | 000 |
00847946023898 | K162832 | 000 |
00847946023843 | K162832 | 000 |
00847946023836 | K162832 | 000 |
00847946023829 | K162832 | 000 |