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 |